21 CFR § 870.3630 Cardiovascular Devices

§ 870.3630 Pacemaker generator function analyzer.

Current through Sep 8, 2026 · Read all of Part 870

⚠ 3 pending changes to Part 870

(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).

← § 870.3620 Pacemaker lead adaptor.§ 870.3640 Indirect pacemaker generator function analyzer. →