AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz

Subsystem, Water Purification

AmeriWater

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.

Pre-market Notification Details

Device IDK142285
510k NumberK142285
Device Name:AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz
ClassificationSubsystem, Water Purification
Applicant AmeriWater 1303 Stanley Avenue Dayton,  OH  45404
ContactBrian R Bowman
CorrespondentBrian R Bowman
AmeriWater 1303 Stanley Avenue Dayton,  OH  45404
Product CodeFIP  
CFR Regulation Number876.5665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-18
Decision Date2014-12-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817927020048 K142285 000
00817927020031 K142285 000
00817927020024 K142285 000

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