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U.S. Department of Health and Human Services

Product Classification
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Device oximeter, wellness
Regulation Description Oximeter.
Definition Pulse oximeter intended for wellness use.
Physical State Used to transmit light at known wavelengths(s) through blood using a light emitting diode(s) and sensor.
Technical Method Transmit light at a known wavelength(s) through blood to measure photoplethysmographic data based on the amount of reflected or scattered light.
Target Area Circulatory pulse
Regulation Medical Specialty Cardiovascular
Review Panel Anesthesiology
Product CodePGJ
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type Enforcement Discretion
Regulation Number 870.2700
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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