21 C.F.R. § 870.3630

Current through September 30, 2024
Section 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).

21 C.F.R. § 870.3630