§868.5830. Autotransfusion apparatus.

21 C.F.R. § 868.5830

(a)

Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.

(b)

Classification. Class II (performance standards).

Notes, amendments, and revision history

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

Source: 47 FR 31142, July 16, 1982, unless otherwise noted.