StacksVerified U.S. regulatory reference

21 CFR §870.3630

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (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.
  2. (b)Classification. Class II (performance standards).