Code of Federal Regulations · Section
§ 870.1750 — External Programmable Pacemaker Pulse Generator
21 C.F.R. § 870.1750
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(a) Identification. An external programmable pacemaker pulse generators is a device that can be programmed to produce one or more pulses at preselected intervals; this device is used in electrophysiological studies.
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351