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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 Opthalmic, Anaesthesia, Respiratory, ENT and Dental Devices (OHT1)
Anethesia, Respiratory, and ENT Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5450
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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