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U.S. Department of Health and Human Services

Product Classification

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Device meter, airway pressure (inspiratory force)
Regulation Description Inspiratory airway pressure meter.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeBXR
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.1780
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
Third Party Review
Accredited Persons
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