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U.S. Department of Health and Human Services

Product Classification

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Device controller, infusion, intravascular, electronic
Regulation Description Infusion pump.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeLDR
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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