The following data is part of a premarket notification filed by Ameriwater with the FDA for Mroz Reverse Osmosis System.
Device ID | K131622 |
510k Number | K131622 |
Device Name: | MROZ REVERSE OSMOSIS SYSTEM |
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 | 2013-06-03 |
Decision Date | 2013-09-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00817927020208 | K131622 | 000 |
00817927020192 | K131622 | 000 |
00817927020185 | K131622 | 000 |
00817927020178 | K131622 | 000 |
00817927020161 | K131622 | 000 |
00817927020154 | K131622 | 000 |