21 C.F.R. § 868.5610 Membrane lung for long-term pulmonary support.
Title 21 - Food and Drugs
(a) Identification. A membrane lung for long-term pulmonary support is a device used to provide to a patient extracorporeal blood oxygenation for longer than 24 hours. (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 §868.3. [47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987]
Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart F—Therapeutic Devices
§ 868.5610 Membrane lung for long-term pulmonary support.