The following data is part of a premarket notification filed by Ameriwater with the FDA for Mediqa Single Pass Reverse Osmosis System With Heat Sanitization, Mediqa Double Pass Reverse Osmosis System With Heat Sa.
| Device ID | K131904 |
| 510k Number | K131904 |
| Device Name: | MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-25 |
| Decision Date | 2013-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817927020130 | K131904 | 000 |
| 00817927020123 | K131904 | 000 |
| 00817927020116 | K131904 | 000 |
| 00817927020109 | K131904 | 000 |
| 00817927020093 | K131904 | 000 |