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U.S. Department of Health and Human Services

Product Classification

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Device humidifier, respiratory gas, (direct patient interface)
Regulation Description Respiratory gas humidifier.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeBTT
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 868.5450
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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