PORTABLE REVERSE OSMOSIS MACHINE

Subsystem, Water Purification

BETTER WATER, INC.

The following data is part of a premarket notification filed by Better Water, Inc. with the FDA for Portable Reverse Osmosis Machine.

Pre-market Notification Details

Device IDK954928
510k NumberK954928
Device Name:PORTABLE REVERSE OSMOSIS MACHINE
ClassificationSubsystem, Water Purification
Applicant BETTER WATER, INC. 698 SWAN DR. Smyrna,  TN  37167
ContactMike Cline
CorrespondentMike Cline
BETTER WATER, INC. 698 SWAN DR. Smyrna,  TN  37167
Product CodeFIP  
CFR Regulation Number876.5665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-26
Decision Date1996-01-24

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