Title 21: Food and Drugs
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/ PART 870 - CARDIOVASCULAR DEVICES
/ Subpart B - Cardiovascular Diagnostic Devices / § 870.1750 External programmable pacemaker pulse generator.
§ 870.1750 External programmable pacemaker pulse generator.
(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).