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U.S. Department of Health and Human Services

Product Classification
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Device oximeter, infrared, sporting, aviation
Regulation Description Oximeter.
Definition Solely for use with sporting and aviation activities. Intended to monitor heart rate during exercise.
Physical State sports watch that emits infrared
Technical Method Non-invasive infrared
Target Area Circulatory pulse
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeOCH
Premarket Review Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
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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