The following data is part of a premarket notification filed by Ameriwater with the FDA for Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1 To 3 Station.
| Device ID | K111740 |
| 510k Number | K111740 |
| Device Name: | AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION |
| Classification | Subsystem, Water Purification |
| Applicant | AMERIWATER 1303 STANLEY AVE. Dayton, OH 45404 |
| Contact | Brian R Bowman |
| Correspondent | Brian R Bowman AMERIWATER 1303 STANLEY AVE. Dayton, OH 45404 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-21 |
| Decision Date | 2011-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817927020017 | K111740 | 000 |
| 00817927020000 | K111740 | 000 |