Definition: Disinfectant Intended For Reprocessing Water Purification Systems For Hemodialysis.
Device Type ID | 2524 |
Device Name | Disinfectant, Subsystem, Water Purification |
Regulation Description | Water Purification System For Hemodialysis. |
Regulation Medical Specialty | Gastroenterology/Urology |
Review Panel | General Hospital |
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 |
CFR Regulation Number | 876.5665 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | NIH |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
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Device Type ID | 2524 |
Device | Disinfectant, Subsystem, Water Purification |
Product Code | NIH |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Water Purification System For Hemodialysis. |
CFR Regulation Number | 876.5665 [🔎] |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
MEDIVATORS REPROCESSING SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDIVATORS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 |
Device Problems | |
---|---|
Adverse Event Without Identified Device Or Use Problem | 2 |
Total Device Problems | 2 |