AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory

Dialyzer, High Permeability With Or Without Sealed Dialysate System

Baxter Healthcare Corportation

The following data is part of a premarket notification filed by Baxter Healthcare Corportation with the FDA for Ak 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory.

Pre-market Notification Details

Device IDK201809
510k NumberK201809
Device Name:AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant Baxter Healthcare Corportation 25212 W. Illinois Route 120 Round Lake,  IL  60073
ContactKristen Bozzelli
CorrespondentKristen Bozzelli
Baxter Healthcare Corportation 25212 W. Illinois Route 120 Round Lake,  IL  60073
Product CodeKDI  
Subsequent Product CodeFIP
Subsequent Product CodeFJK
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-01
Decision Date2021-03-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07332414124519 K201809 000
37332414102501 K201809 000

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