21 CFR 870.2710
§ 870.2710 Ear oximeter.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 870.2710, § 870.2710 Ear oximeter, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89935
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.