Code of Federal Regulations · Section

§ 870.2710 — Ear Oximeter

21 C.F.R. § 870.2710

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(a) Identification. An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.

(b) Classification. Class II (performance standards).

21 C.F.R. § 870.2700 21 C.F.R. § 870.2750

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