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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 Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5270
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 Standards
Third Party Review
Accredited Persons
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