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U.S. Department of Health and Human Services

Product Classification

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Device pump, infusion, analytical sampling
Regulation Description Infusion pump.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeLZF
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 Standard
Third Party Review
Accredited Persons

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