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U.S. Department of Health and Human Services

Product Classification
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Device pulse oximeter for over-the-counter use
Regulation Description Oximeter.
Definition Non-wearable, fingertip pulse oximeter intended for over-the-counter use for non-continuous monitoring
Physical State Used to transmit light at known wavelengths(s) through blood using a light emitting diode(s) and photodetector.
Technical Method The device transmits radiation at a known wavelength(s) through blood and measures the blood oxygen saturation based on the amount of reflected or scattered radiation.
Target Area Peripheral circulatory pulse.
Regulation Medical Specialty Cardiovascular
Review Panel Anesthesiology
Product CodeOLK
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 870.2700
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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