Homechoice Claria APD System, Sharesource Connectivity Platform For Use With The Homechoice Claria APD System

System, Peritoneal, Automatic Delivery

Baxter Healthcare Corporation

The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Homechoice Claria Apd System, Sharesource Connectivity Platform For Use With The Homechoice Claria Apd System.

Pre-market Notification Details

Device IDK201867
510k NumberK201867
Device Name:Homechoice Claria APD System, Sharesource Connectivity Platform For Use With The Homechoice Claria APD System
ClassificationSystem, Peritoneal, Automatic Delivery
Applicant Baxter Healthcare Corporation 25212 W. Illinois Route 120 Round Lake,  IL  60073
ContactBrad Roynon
CorrespondentBrad Roynon
Baxter Healthcare Corporation 25212 W. Illinois Route 120 Round Lake,  IL  60073
Product CodeFKX  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-07
Decision Date2020-11-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50085412676468 K201867 000

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