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U.S. Department of Health and Human Services

Product Classification

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Device gas-machine, anesthesia
Regulation Description Gas machine for anesthesia or analgesia.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeBSZ
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5160
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? Yes
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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