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U.S. Department of Health and Human Services

Product Classification
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Device monitor for opioid induced impairment of oxygenation
Definition A monitor for opioid induced impairment of oxygenation is a device that uses sensor hardware and software algorithms to detect desaturations of arterial oxygen saturation resulting from opioid overdose
Physical State Software/algorithm
Technical Method Analyzes physiologic sensor data to detect opioid induced impairment of oxygenation
Target Area Peripheral circulatory pulse
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeQVT
Premarket Review Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.2250
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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