GroundRules
21 CFR 870.1750: External programmable pacemaker pulse generator.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 870—CARDIOVASCULAR DEVICES
- Subpart B—Cardiovascular Diagnostic Devices
(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).
Collected 2026-08-27T02:24:47Z. Source file · JSON