NIH · Disinfectant, Subsystem, Water Purification
Gastroenterology, Urology · 21 CFR 876.5665 · Class 2
Overview
| Product Code | NIH |
|---|---|
| Device Name | Disinfectant, Subsystem, Water Purification |
| Regulation | 21 CFR 876.5665 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.
Classification Rationale
Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K133724 | MINNCARE HD | Medivators, Inc. | Aug 27, 2014 | SESE |
Top Applicants
- Medivators, Inc. — 1 clearance
