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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 868 - Anesthesiology Devices |
| Subpart A - General Provisions |
| § 868.1 - Scope. |
| § 868.3 - Effective dates of requirement for premarket approval. |
| § 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
| Subpart B - Diagnostic Devices |
| § 868.1030 - Manual algesimeter. |
| § 868.1040 - Powered algesimeter. |
| § 868.1075 - Argon gas analyzer. |
| § 868.1100 - Arterial blood sampling kit. |
| § 868.1120 - Indwelling blood oxyhemoglobin concentration analyzer. |
| § 868.1150 - Indwelling blood carbon dioxide partial pressure (P2CO2) analyzer. |
| § 868.1170 - Indwelling blood hydrogen ion concentration (pH) analyzer. |
| § 868.1200 - Indwelling blood oxygen partial pressure (PO2) analyzer. |
| § 868.1400 - Carbon dioxide gas analyzer. |
| § 868.1430 - Carbon monoxide gas analyzer. |
| § 868.1500 - Enflurane gas analyzer. |
| § 868.1505 - Ventilatory electrical impedance tomograph. |
| § 868.1575 - Gas collection vessel. |
| § 868.1620 - Halothane gas analyzer. |
| § 868.1640 - Helium gas analyzer. |
| § 868.1670 - Neon gas analyzer. |
| § 868.1690 - Nitrogen gas analyzer. |
| § 868.1700 - Nitrous oxide gas analyzer. |
| § 868.1720 - Oxygen gas analyzer. |
| § 868.1730 - Oxygen uptake computer. |
| § 868.1750 - Pressure plethysmograph. |
| § 868.1760 - Volume plethysmograph. |
| § 868.1780 - Inspiratory airway pressure meter. |
| § 868.1800 - Rhinoanemometer. |
| § 868.1840 - Diagnostic spirometer. |
| § 868.1850 - Monitoring spirometer. |
| § 868.1860 - Peak-flow meter for spirometry. |
| § 868.1870 - Gas volume calibrator. |
| § 868.1880 - Pulmonary-function data calculator. |
| § 868.1890 - Predictive pulmonary-function value calculator. |
| § 868.1900 - Diagnostic pulmonary-function interpretation calculator. |
| § 868.1910 - Esophageal stethoscope. |
| § 868.1920 - Esophageal stethoscope with electrical conductors. |
| § 868.1930 - Stethoscope head. |
| § 868.1965 - Switching valve (ploss). |
| § 868.1975 - Water vapor analyzer. |
| Subpart C - Monitoring Devices |
| § 868.2025 - Ultrasonic air embolism monitor. |
| § 868.2300 - Bourdon gauge flowmeter. |
| § 868.2320 - Uncompensated thorpe tube flowmeter. |
| § 868.2340 - Compensated thorpe tube flowmeter. |
| § 868.2350 - Gas calibration flowmeter. |
| § 868.2375 - Breathing frequency monitor. |
| § 868.2377 - Apnea monitor. |
| § 868.2380 - Nitric oxide analyzer. |
| § 868.2385 - Nitrogen dioxide analyzer. |
| § 868.2450 - Lung water monitor. |
| § 868.2480 - Cutaneous carbon dioxide (PcCO2) monitor. |
| § 868.2500 - Cutaneous oxygen (PcO2) monitor. |
| § 868.2550 - Pneumotachometer. |
| § 868.2600 - Airway pressure monitor. |
| § 868.2610 - Gas pressure gauge. |
| § 868.2620 - Gas pressure calibrator. |
| § 868.2700 - Pressure regulator. |
| § 868.2775 - Electrical peripheral nerve stimulator. |
| § 868.2875 - Differential pressure transducer. |
| § 868.2885 - Gas flow transducer. |
| § 868.2900 - Gas pressure transducer. |
| Subparts D--E - XXX |
| Subpart F - Therapeutic Devices |
| § 868.5090 - Emergency airway needle. |
| § 868.5095 - Retrograde intubation device. |
| § 868.5100 - Nasopharyngeal airway. |
| § 868.5105 - External negative pressure airway aid. |
| § 868.5110 - Oropharyngeal airway. |
| § 868.5115 - Device to relieve acute upper airway obstruction. |
| § 868.5120 - Anesthesia conduction catheter. |
| § 868.5130 - Anesthesia conduction filter. |
| § 868.5140 - Anesthesia conduction kit. |
| § 868.5150 - Anesthesia conduction needle. |
| § 868.5160 - Gas machine for anesthesia or analgesia. |
| § 868.5165 - Nitric oxide administration apparatus. |
| § 868.5170 - Laryngotracheal topical anesthesia applicator. |
| § 868.5180 - Rocking bed. |
| § 868.5220 - Blow bottle. |
| § 868.5240 - Anesthesia breathing circuit. |
| § 868.5250 - Breathing circuit circulator. |
| § 868.5260 - Breathing circuit bacterial filter. |
| § 868.5270 - Breathing system heater. |
| § 868.5273 - Positive airway pressure delivery system. |
| § 868.5280 - Breathing tube support. |
| § 868.5300 - Carbon dioxide absorbent. |
| § 868.5310 - Carbon dioxide absorber. |
| § 868.5320 - Reservoir bag. |
| § 868.5330 - Breathing gas mixer. |
| § 868.5340 - Nasal oxygen cannula. |
| § 868.5350 - Nasal oxygen catheter. |
| § 868.5365 - Posture chair for cardiac or pulmonary treatment. |
| § 868.5375 - Heat and moisture condenser (artificial nose). |
| § 868.5400 - Electroanesthesia apparatus. |
| § 868.5420 - Ether hook. |
| § 868.5430 - Gas-scavenging apparatus. |
| § 868.5440 - Portable oxygen generator. |
| § 868.5450 - Respiratory gas humidifier. |
| § 868.5454 - High flow humidified oxygen delivery device. |
| § 868.5460 - Therapeutic humidifier for home use. |
| § 868.5470 - Hyperbaric chamber. |
| § 868.5480 - Isocapnic ventilation device. |
| § 868.5530 - Flexible laryngoscope. |
| § 868.5540 - Rigid laryngoscope. |
| § 868.5550 - Anesthetic gas mask. |
| § 868.5560 - Gas mask head strap. |
| § 868.5570 - Nonrebreathing mask. |
| § 868.5580 - Oxygen mask. |
| § 868.5590 - Scavenging mask. |
| § 868.5600 - Venturi mask. |
| § 868.5610 - Membrane lung for long-term pulmonary support. |
| § 868.5620 - Breathing mouthpiece. |
| § 868.5630 - Nebulizer. |
| § 868.5640 - Medicinal nonventilatory nebulizer (atomizer). |
| § 868.5650 - Esophageal obturator. |
| § 868.5655 - Portable liquid oxygen unit. |
| § 868.5665 - Powered percussor. |
| § 868.5675 - Rebreathing device. |
| § 868.5690 - Incentive spirometer. |
| § 868.5700 - Nonpowered oxygen tent. |
| § 868.5710 - Electrically powered oxygen tent. |
| § 868.5720 - Bronchial tube. |
| § 868.5730 - Tracheal tube. |
| § 868.5740 - Tracheal/bronchial differential ventilation tube. |
| § 868.5750 - Inflatable tracheal tube cuff. |
| § 868.5760 - Cuff spreader. |
| § 868.5770 - Tracheal tube fixation device. |
| § 868.5780 - Tube introduction forceps. |
| § 868.5790 - Tracheal tube stylet. |
| § 868.5795 - Tracheal tube cleaning brush. |
| § 868.5800 - Tracheostomy tube and tube cuff. |
| § 868.5810 - Airway connector. |
| § 868.5820 - Dental protector. |
| § 868.5830 - Autotransfusion apparatus. |
| § 868.5860 - Pressure tubing and accessories. |
| § 868.5870 - Nonrebreathing valve. |
| § 868.5880 - Anesthetic vaporizer. |
| § 868.5895 - Continuous ventilator. |
| § 868.5905 - Noncontinuous ventilator (IPPB). |
| § 868.5915 - Manual emergency ventilator. |
| § 868.5925 - Powered emergency ventilator. |
| § 868.5935 - External negative pressure ventilator. |
| § 868.5955 - Intermittent mandatory ventilation attachment. |
| § 868.5965 - Positive end expiratory pressure breathing attachment. |
| § 868.5975 - Ventilator tubing. |
| § 868.5995 - Tee drain (water trap). |
| Subpart G - Miscellaneous |
| § 868.6100 - Anesthetic cabinet, table, or tray. |
| § 868.6175 - Cardiopulmonary emergency cart. |
| § 868.6225 - Nose clip. |
| § 868.6250 - Portable air compressor. |
| § 868.6400 - Calibration gas. |
| § 868.6700 - Anesthesia stool. |
| § 868.6810 - Tracheobronchial suction catheter. |
| § 868.6820 - Patient position support. |
| § 868.6885 - Medical gas yoke assembly. |