Device Classification Name |
tank, holding, dialysis
|
510(k) Number |
K141213 |
Device Name |
AMERIWATER OZONE DISINFECTION SYSTEM |
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 Number | 876.5820
|
Classification Product Code |
|
Date Received | 05/12/2014 |
Decision Date | 12/10/2014 |
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
|
|
|