Code of Federal Regulations · Section

§ 870.3630 — Pacemaker Generator Function Analyzer

21 C.F.R. § 870.3630

View:

(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).

21 C.F.R. § 870.3620 21 C.F.R. § 870.3640

Authorizing Statute