Fresenius Liberty Select Cycler

System, Peritoneal, Automatic Delivery

Fresenius Medical Care Renal Therapies Group, LLC

The following data is part of a premarket notification filed by Fresenius Medical Care Renal Therapies Group, Llc with the FDA for Fresenius Liberty Select Cycler.

Pre-market Notification Details

Device IDK171652
510k NumberK171652
Device Name:Fresenius Liberty Select Cycler
ClassificationSystem, Peritoneal, Automatic Delivery
Applicant Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham,  MA  02451
ContactDenise Oppermann
CorrespondentDenise Oppermann
Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham,  MA  02451
Product CodeFKX  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-05
Decision Date2017-09-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840861102068 K171652 000

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