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§870.2700. Oximeter.

21 C.F.R. § 870.2700

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.
(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: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.