GroundRules
21 CFR 870.3630: Pacemaker generator function analyzer.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 870—CARDIOVASCULAR DEVICES
- Subpart D—Cardiovascular Prosthetic Devices
(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).
Collected 2026-08-27T02:24:47Z. Source file · JSON