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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 870 - Cardiovascular Devices |
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Subpart D - Cardiovascular Prosthetic Devices |
§ 870.3630 - Pacemaker generator function analyzer.
Latest version.
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§ 870.3630 Pacemaker generator function analyzer.
(a) Identification. A pacemaker generator function analyzer is a device that is connected to a pacemaker pulse generator to test any or all of the generator's parameters, including pulse duration, pulse amplitude, pulse rate, and sensing threshold.
(b) Classification. Class II (performance standards).