EON Portable Reverse Osmosis Water Purification System

Subsystem, Water Purification

Cantel

The following data is part of a premarket notification filed by Cantel with the FDA for Eon Portable Reverse Osmosis Water Purification System.

Pre-market Notification Details

Device IDK171099
510k NumberK171099
Device Name:EON Portable Reverse Osmosis Water Purification System
ClassificationSubsystem, Water Purification
Applicant Cantel 14550 28th Avenue North Minneapolis,  MN  55447
ContactMike Halliday
CorrespondentKatlin Adamski
Cantel 14605 28th Avenue North Minneapolis,  MN  55447
Product CodeFIP  
CFR Regulation Number876.5665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-13
Decision Date2018-01-05
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.