Code of Federal Regulations · Section
§ 870.2700 — Oximeter
21 C.F.R. § 870.2700
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(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).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351