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U.S. Department of Health and Human Services

Product Classification

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Device heater, breathing system w/wo controller (not humidifier or nebulizer
Regulation Description Breathing system heater.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeBZE
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Respiratory Devices Branch (RPDB)
Submission Type 510(k)
Regulation Number 868.5270
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review
Accredited Persons

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