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U.S. Department of Health and Human Services

Product Classification

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Device disinfectant, subsystem, water purification
Regulation Description Water purification system for hemodialysis.
Definition Disinfectant intended for reprocessing water purification systems for hemodialysis.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel General Hospital
Product CodeNIH
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) Exempt
Regulation Number 876.5665
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act.
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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