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U.S. Department of Health and Human Services

Product Classification

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Device ventilator, external body, negative pressure, adult (cuirass)
Regulation Description External negative pressure ventilator.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeBYT
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 868.5935
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Draft Reviewer Guidance for Ventilators [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080607.pdf] 
Third Party Review
Accredited Persons

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