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U.S. Department of Health and Human Services

Product Classification

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Device generator, oxygen, portable
Regulation Description Portable oxygen generator.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeCAW
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 868.5440
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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