FDA 510(k) K201867, Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System, by Baxter Healthcare Corporation

FDA 510(k) K201867, Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System, by Baxter Healthcare Corporation

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Device Classification Name: System, Peritoneal, Automatic Delivery
510(k) Number: K201867
Device Name: Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System
Applicant: Baxter Healthcare Corporation
Regulation Number: 876.563
Classification Product Code: FKX
Date Received: 07/07/2020
Decision Date: 11/19/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
510k Review Panel: Gastroenterology/Urology

Total number of pages: 84
Fully redacted pages: 53
Content pages: 31

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