---

21 C.F.R. § 870.3630   Pacemaker generator function analyzer.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart D—Cardiovascular Prosthetic Devices

Browse Previous |  Browse Next

§ 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).

Browse Previous |  Browse Next