Title 21: Food and Drugs
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/ PART 870 - CARDIOVASCULAR DEVICES
/ Subpart D - Cardiovascular Prosthetic Devices / § 870.3630 Pacemaker generator function analyzer.
§ 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).