The following data is part of a premarket notification filed by Ameriwater with the FDA for Ameriwater Ozone Disinfection System.
| Device ID | K141213 |
| 510k Number | K141213 |
| Device Name: | AMERIWATER OZONE DISINFECTION SYSTEM |
| Classification | Tank, Holding, Dialysis |
| Applicant | AMERIWATER 1303 STANLEY AVE. Dayton, OH 45404 |
| Contact | Brian Bowman |
| Correspondent | Brian Bowman AMERIWATER 1303 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 | 2014-05-12 |
| Decision Date | 2014-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817927020086 | K141213 | 000 |