The following data is part of a premarket notification filed by Ameriwater with the FDA for Ameriwater Alarm Panel - Base Model And Remote, Base Model & Remote With Conductivity, Base Model & Remote With Resistiv.
Device ID | K121022 |
510k Number | K121022 |
Device Name: | AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV |
Classification | Subsystem, Water Purification |
Applicant | AMERIWATER 1303 STANLEY AVE. Dayton, OH 45404 |
Contact | Brian Bowman |
Correspondent | Brian 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 | 2012-04-04 |
Decision Date | 2012-09-17 |
Summary: | summary |