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U.S. Department of Health and Human Services

Product Classification
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Device positive airway pressure system
Regulation Description Positive airway pressure delivery system.
Definition A positive airway pressure delivery system is a prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea. The system may include a dedicated flow generator and a patient interface.
Physical State Mask and flow generator
Technical Method Use of a mask and a flow generator by a patient while sleeping.
Target Area Nasopharynx
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeQBY
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 868.5273
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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