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U.S. Department of Health and Human Services

Product Classification
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Device pulse oximeter for low-acuity settings
Regulation Description Oximeter.
Definition Pulse oximeter intended for low-acuity settings.
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 Peripheral circulatory pulse.
Regulation Medical Specialty Cardiovascular
Review Panel Anesthesiology
Product CodeQLS
Premarket Review Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
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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