The following data is part of a premarket notification filed by Ameriwater with the FDA for Portable Ro+ Model Mros09.
Device ID | K030059 |
510k Number | K030059 |
Device Name: | PORTABLE RO+ MODEL MROS09 |
Classification | Subsystem, Water Purification |
Applicant | AMERIWATER 1257 STANLEY AVE. Dayton, OH 45404 |
Contact | Brian R Bowman |
Correspondent | Brian 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 | 2003-01-07 |
Decision Date | 2003-04-07 |
Summary: | summary |