PORTABLE REVERSE OSMOSIS MACHINE
Device Facts
| Record ID | K954928 |
|---|---|
| Device Name | PORTABLE REVERSE OSMOSIS MACHINE |
| Applicant | Better Water, Inc. |
| Product Code | FIP · Gastroenterology, Urology |
| Decision Date | Jan 24, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5665 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
