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Electronic Code of Federal Regulations

e-CFR data is current as of February 26, 2020

Title 21Chapter ISubchapter HPart 870Subpart C → §870.2710


Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart C—Cardiovascular Monitoring Devices


§870.2710   Ear oximeter.

(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).

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