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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 Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Anesthesiology Devices Branch (ANDB)
Submission Type Enforcement Discretion
Regulation Number 870.2700
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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