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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 Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Anesthesiology Devices Branch (ANDB)
Submission Type 510(k)
Regulation Number 868.5160
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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