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U.S. Department of Health and Human Services

Product Classification

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Device pump, infusion
Regulation Description Infusion pump.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeFRN
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 880.5725
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Documents
  • Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm206153.htm] 
  • Guidance on the Content of Premarket Notification [510(k)] Submissions for External Infusion Pumps
Third Party Review
Accredited Persons

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