21 C.F.R. § 870.3630

Pacemaker generator function analyzer.

Last amended: 2016Year: 2026Length: 43 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 870.3630 (2026)

(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. § 870.3630: Pacemaker generator function analyzer. | Justis AI