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U.S. Department of Health and Human Services

Product Classification

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Device monitor, apnea, facility use
Regulation Description Apnea monitor.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeFLS
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.2377
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? Yes
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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