FDA 510(k)

Change Healthcare Cardiology Hemodynamics

K-Number: K230881 · 2023-09-11

ApplicantChange Healthcare Israel , Ltd.

Decision Date2023-09-11

Product CodeMWI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Change Healthcare Cardiology Hemodynamics is a medical device manufactured by Change Healthcare Israel , Ltd.. It received FDA 510(k) clearance on 2023-09-11 under approval number K230881. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Change Healthcare Cardiology Hemodynamics?

Change Healthcare Cardiology Hemodynamics is a medical device that received FDA 510(k) clearance on 2023-09-11. It is manufactured by Change Healthcare Israel , Ltd.. The 510(k) number is K230881.

When was Change Healthcare Cardiology Hemodynamics approved by the FDA?

Change Healthcare Cardiology Hemodynamics received FDA 510(k) clearance on 2023-09-11, under approval number K230881.

What company makes Change Healthcare Cardiology Hemodynamics?

Change Healthcare Cardiology Hemodynamics is manufactured by Change Healthcare Israel , Ltd..

What is the FDA product code for Change Healthcare Cardiology Hemodynamics?

The FDA product code for Change Healthcare Cardiology Hemodynamics is MWI.

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Related PubMed Literature

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Official Source

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