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Code of Federal Regulations (Last Updated: July 5, 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 870 - Cardiovascular Devices |
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Subpart B - Cardiovascular Diagnostic Devices |
§ 870.1750 - External programmable pacemaker pulse generator.
Latest version.
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§ 870.1750 External programmable pacemaker pulse generator.
(a) Identification. An external programmable pacemaker pulse generators is a device that can be programmed to produce one or more pulses at preselected intervals; this device is used in electrophysiological studies.
(b) Classification. Class II (performance standards).