The following data is part of a premarket notification filed by Ameriwater with the FDA for Ameriwater Solution Mix And Distribution System For Hemodialysis.
| Device ID | K051031 |
| 510k Number | K051031 |
| Device Name: | AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS |
| Classification | Tank, Holding, Dialysis |
| Applicant | AMERIWATER 1257 STANLEY AVE. Dayton, OH 45404 |
| Contact | Brian R Bowman |
| Correspondent | Brian R Bowman AMERIWATER 1257 STANLEY AVE. Dayton, OH 45404 |
| Product Code | FIN |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-22 |
| Decision Date | 2006-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817927020314 | K051031 | 000 |
| 00817927020307 | K051031 | 000 |
| 00817927020291 | K051031 | 000 |
| 00817927020284 | K051031 | 000 |
| 00817927020079 | K051031 | 000 |
| 00817927020062 | K051031 | 000 |
| 00817927020055 | K051031 | 000 |