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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 Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Respiratory Devices Branch (RPDB)
Submission Type 510(k)
Regulation Number 868.5905
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons