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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name subsystem, water purification
510(k) Number K121022
Device Name AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV
Applicant
AMERIWATER
1303 STANLEY AVE.
DAYTON,  OH  45404
Applicant Contact BRIAN BOWMAN
Correspondent
AMERIWATER
1303 STANLEY AVE.
DAYTON,  OH  45404
Correspondent Contact BRIAN BOWMAN
Regulation Number876.5665
Classification Product Code
FIP  
Date Received04/04/2012
Decision Date 09/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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