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U.S. Department of Health and Human Services

Product Classification

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Device ventilator, continuous, minimal ventilatory support,facility use
Regulation Description Continuous ventilator.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeMNT
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 868.5895
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Draft Reviewer Guidance for Ventilators [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080607.pdf] 
Third Party Review Not Third Party Eligible
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