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U.S. Department of Health and Human Services

Product Classification

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Device injector, fluid, non-electrically powered
Regulation Description Nonelectrically powered fluid injector.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeKZE
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 880.5430
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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