21 C.F.R. § 870.5200 External cardiac compressor.
Title 21 - Food and Drugs
(a) Identification. An external cardiac compressor is an external device that is electrically, pneumatically, or manually powered and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See §870.3. [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987]
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart F—Cardiovascular Therapeutic Devices
§ 870.5200 External cardiac compressor.
