§870.3630. Pacemaker generator function analyzer.
21 C.F.R. § 870.3630
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.
Classification. Class II (performance standards).
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.