1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 870 - CARDIOVASCULAR DEVICES
  6. Subpart D - Cardiovascular Prosthetic Devices
  7. 21 CFR § 870.3630
21 CFR § 870.3630
Pacemaker generator function analyzer
June 25, 2020
CFR

(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).

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§ 870.3620 Pacemaker lead adaptor
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§ 870.3640 Indirect pacemaker generator function analyzer

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