Device Classification Name |
Subsystem, Water Purification
|
510(k) Number |
K142285 |
Device Name |
AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz |
Applicant |
AmeriWater |
1303 Stanley Avenue |
Dayton,
OH
45404
|
|
Applicant Contact |
Brian R Bowman |
Correspondent |
AmeriWater |
1303 Stanley Avenue |
Dayton,
OH
45404
|
|
Correspondent Contact |
Brian R Bowman |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 08/18/2014 |
Decision Date | 12/01/2014 |
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
|
|
|