2008T BlueStar Hemodailysis Machine

Dialyzer, High Permeability With Or Without Sealed Dialysate System

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 2008t Bluestar Hemodailysis Machine.

Pre-market Notification Details

Device IDK222952
510k NumberK222952
Device Name:2008T BlueStar Hemodailysis Machine
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham,  MA  02451
ContactDenise M Oppermann
CorrespondentDenise M Oppermann
Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham,  MA  02451
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-09-27
Decision Date2022-10-27

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