The following data is part of a premarket notification filed by Dayton Water Systems with the FDA for Ultrapure Water Treatment System For Hemodialysis.
| Device ID | K981680 |
| 510k Number | K981680 |
| Device Name: | ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS |
| Classification | Subsystem, Water Purification |
| Applicant | DAYTON WATER SYSTEMS 1288 MCCOOK AVE. Dayton, OH 45404 |
| Contact | Cindy Helton |
| Correspondent | Cindy Helton DAYTON WATER SYSTEMS 1288 MCCOOK AVE. Dayton, OH 45404 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-13 |
| Decision Date | 1998-12-31 |
| Summary: | summary |