AquaA

Subsystem, Water Purification

Fresenius Medical Care Rental Therapies Group, LLC

The following data is part of a premarket notification filed by Fresenius Medical Care Rental Therapies Group, Llc with the FDA for Aquaa.

Pre-market Notification Details

Device IDK213507
510k NumberK213507
Device Name:AquaA
ClassificationSubsystem, Water Purification
Applicant Fresenius Medical Care Rental Therapies Group, LLC 920 Winter Street Waltham,  MA  02451
ContactDenise Oppermann
CorrespondentDenise Oppermann
Fresenius Medical Care Rental Therapies Group, LLC 920 Winter Street Waltham,  MA  02451
Product CodeFIP  
CFR Regulation Number876.5665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-01
Decision Date2022-07-27

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