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FDA 510(k)

Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System

K-Number: K201867 · 2020-11-19

ApplicantBaxter Healthcare Corporation
Decision Date2020-11-19
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System is a medical device manufactured by Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2020-11-19 under approval number K201867. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System?

Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System is a medical device that received FDA 510(k) clearance on 2020-11-19. It is manufactured by Baxter Healthcare Corporation. The 510(k) number is K201867.

When was Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System approved by the FDA?

Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System received FDA 510(k) clearance on 2020-11-19, under approval number K201867.

What company makes Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System?

Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System is manufactured by Baxter Healthcare Corporation.

What is the FDA product code for Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System?

The FDA product code for Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System is FKX.

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Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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