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U.S. Department of Health and Human Services

Product Classification

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Device mixer, breathing gases, anesthesia inhalation
Regulation Description Breathing gas mixer.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeBZR
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5330
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? Yes
Recognized Consensus Standards
Third Party Review
Accredited Persons
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