MROZ REVERSE OSMOSIS SYSTEM

Subsystem, Water Purification

AMERIWATER

The following data is part of a premarket notification filed by Ameriwater with the FDA for Mroz Reverse Osmosis System.

Pre-market Notification Details

Device IDK131622
510k NumberK131622
Device Name:MROZ REVERSE OSMOSIS SYSTEM
ClassificationSubsystem, Water Purification
Applicant AMERIWATER 1303 STANLEY AVE. Dayton,  OH  45404
ContactBrian R Bowman
CorrespondentBrian R Bowman
AMERIWATER 1303 STANLEY AVE. Dayton,  OH  45404
Product CodeFIP  
CFR Regulation Number876.5665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-03
Decision Date2013-09-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817927020208 K131622 000
00817927020192 K131622 000
00817927020185 K131622 000
00817927020178 K131622 000
00817927020161 K131622 000
00817927020154 K131622 000

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