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U.S. Department of Health and Human Services

Product Classification

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Device valve, non-rebreathing
Regulation Description Nonrebreathing valve.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeCBP
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 868.5870
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Draft Reviewer Guidance on Face Masks and Shield for CPR [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM081256.pdf] 
Third Party Review
Accredited Persons

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