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FDA 510(k)

RadCalc 软件

K号: K193381 · 2019-12-31

决定日期2019-12-31
产品代码MUJ
咨询委员会RA
决定实质等同

器械摘要

RadCalc Software is the device name listed in this FDA 510(k) record. The listed applicant is Lifeline Software, Inc.. It received FDA 510(k) clearance on 2019-12-31 under 510(k) number K193381. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RadCalc Software?

RadCalc Software is a medical device that received FDA 510(k) clearance on 2019-12-31. The listed applicant is Lifeline Software, Inc.. The 510(k) number is K193381.

When did RadCalc Software receive FDA 510(k) clearance?

RadCalc Software received FDA 510(k) clearance on 2019-12-31, under 510(k) number K193381.

Who is the listed applicant for RadCalc Software?

The FDA 510(k) record lists Lifeline Software, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RadCalc Software?

The FDA product code for RadCalc Software is MUJ.

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相关器械(代码:MUJ)

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