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FDA 510(k)

Change Healthcare Cardiology

K号: K212528 · 2021-10-18

决定日期2021-10-18
产品代码LLZ
咨询委员会RA
决定实质等同

器械摘要

Change Healthcare Cardiology is the device name listed in this FDA 510(k) record. The listed applicant is Change Healthcare Israel , Ltd.. It received FDA 510(k) clearance on 2021-10-18 under 510(k) number K212528. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Change Healthcare Cardiology?

Change Healthcare Cardiology is a medical device that received FDA 510(k) clearance on 2021-10-18. The listed applicant is Change Healthcare Israel , Ltd.. The 510(k) number is K212528.

When did Change Healthcare Cardiology receive FDA 510(k) clearance?

Change Healthcare Cardiology received FDA 510(k) clearance on 2021-10-18, under 510(k) number K212528.

Who is the listed applicant for Change Healthcare Cardiology?

The FDA 510(k) record lists Change Healthcare Israel , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Change Healthcare Cardiology?

The FDA product code for Change Healthcare Cardiology is LLZ.

相关临床试验

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列明Change Healthcare Israel , Ltd.为申报人的其他记录

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相关器械(代码:LLZ)

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官方来源

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