The following data is part of a premarket notification filed by Ameriwater with the FDA for Ameriwater Purification System For Hemodialysis.
| Device ID | K991519 |
| 510k Number | K991519 |
| Device Name: | AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
| Classification | Subsystem, Water Purification |
| Applicant | AMERIWATER 1257 STANLEY AVE. Dayton, OH 45404 |
| Contact | Sandra E Monsman |
| Correspondent | Sandra E Monsman AMERIWATER 1257 STANLEY 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 | 1999-04-30 |
| Decision Date | 2000-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817927020277 | K991519 | 000 |
| 00817927020260 | K991519 | 000 |
| 00817927020253 | K991519 | 000 |
| 00817927020246 | K991519 | 000 |
| 00817927020239 | K991519 | 000 |
| 00817927020222 | K991519 | 000 |
| 00817927020338 | K991519 | 000 |