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U.S. Department of Health and Human Services

Product Classification

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Device conserver, oxygen
Regulation Description Noncontinuous ventilator (IPPB).
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeNFB
Premarket Review Opthalmic, Anaesthesia, Respiratory, ENT and Dental Devices (OHT1)
Anethesia, Respiratory, and ENT Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5905
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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