21 CFR 870.2710 — Oximeter, Ear

Cardiovascular (CV) · Part 870 Subpart C—Cardiovascular Monitoring Devices · § 870.2710

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.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
DPZOximeter, Ear211
Innolitics

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