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§868.2025. Ultrasonic air embolism monitor.

21 C.F.R. § 868.2025

(a)
Identification. An ultrasonic air embolism monitor is a device used to detect air bubbles in a patient's blood stream. It may use Doppler or other ultrasonic principles.
(b)
Classification. Class II (performance standards).
Notes, amendments, and revision history

Authority

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

Source

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