 |
Code of Federal Regulations (Last Updated: July 5, 2024) |
 |
Title 21 - Food and Drugs |
|
Chapter I - Food and Drug Administration, Department of Health and Human Services |
|
SubChapter H - Medical Devices |
|
Part 892 - Radiology Devices |
|
Subpart B - Diagnostic Devices |
§ 892.1970 - Radiographic ECG/respirator synchronizer.
Latest version.
-
§ 892.1970 Radiographic ECG/respirator synchronizer.
(a) Identification. A radiographic ECG/respirator synchronizer is a device intended to be used to coordinate an x-ray film exposure with the signal from an electrocardiograph (ECG) or respirator at a predetermined phase of the cardiac or respiratory cycle.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
[55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2323, Jan. 14, 2000]