The following data is part of a premarket notification filed by Ameriwater with the FDA for Modification To Ameriwater Purification System For Hemodialysis.
| Device ID | K021560 |
| 510k Number | K021560 |
| Device Name: | MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
| Classification | Subsystem, Water Purification |
| Applicant | AMERIWATER 1257 STANLEY AVE. Dayton, OH 45404 |
| Contact | Brain R Bowman |
| Correspondent | Brain R Bowman 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 | 2002-05-13 |
| Decision Date | 2003-08-14 |
| Summary: | summary |