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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 Opthalmic, Anaesthesia, Respiratory, ENT and Dental Devices (OHT1)
Anethesia, Respiratory, and ENT 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
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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