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U.S. Department of Health and Human Services

Product Classification

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Device vaporizer, anesthesia, non-heated
Regulation Description Anesthetic vaporizer.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeCAD
Premarket Review Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5880
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
Accredited Persons
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