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U.S. Department of Health and Human Services

Product Classification

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Device monitor, carbon-dioxide, cutaneous
Regulation Description Cutaneous carbon dioxide (PcCO2) monitor.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeLKD
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.2480
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
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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