The following data is part of a premarket notification filed by Ameriwater with the FDA for Ameriwater Heatsan, 3-phase, 208v, 60hz, Ameriwater Heatsan, 3-phase, 460v, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz.
Device ID | K142285 |
510k Number | K142285 |
Device Name: | AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz |
Classification | Subsystem, Water Purification |
Applicant | AmeriWater 1303 Stanley Avenue Dayton, OH 45404 |
Contact | Brian R Bowman |
Correspondent | Brian R Bowman AmeriWater 1303 Stanley Avenue 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 | 2014-08-18 |
Decision Date | 2014-12-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00817927020048 | K142285 | 000 |
00817927020031 | K142285 | 000 |
00817927020024 | K142285 | 000 |