EON Portable RO Water Purification System

Subsystem, Water Purification

Mar Cor Purification, Inc.

The following data is part of a premarket notification filed by Mar Cor Purification, Inc. with the FDA for Eon Portable Ro Water Purification System.

Pre-market Notification Details

Device IDK200670
510k NumberK200670
Device Name:EON Portable RO Water Purification System
ClassificationSubsystem, Water Purification
Applicant Mar Cor Purification, Inc. 14550 28th Avenue North Minneapolis,  MN  55447
ContactMark Arnold
CorrespondentMark Arnold
Mar Cor Purification, Inc. 14550 28th Avenue North Minneapolis,  MN  55447
Product CodeFIP  
CFR Regulation Number876.5665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-13
Decision Date2020-04-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817492022546 K200670 000
00817492023710 K200670 000

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