FDA 510(k)

CryoRobot Select 系统

K号: K221086 · 2022-11-04

决定日期2022-11-04

产品代码QUJ

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决定实质等同

器械摘要

CryoRobot Select System is the device name listed in this FDA 510(k) record. The listed applicant is Tmrw Life Sciences, Inc.. It received FDA 510(k) clearance on 2022-11-04 under 510(k) number K221086. The device is classified under product code QUJ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CryoRobot Select System?

CryoRobot Select System is a medical device that received FDA 510(k) clearance on 2022-11-04. The listed applicant is Tmrw Life Sciences, Inc.. The 510(k) number is K221086.

When did CryoRobot Select System receive FDA 510(k) clearance?

CryoRobot Select System received FDA 510(k) clearance on 2022-11-04, under 510(k) number K221086.

Who is the listed applicant for CryoRobot Select System?

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

What is the FDA product code for CryoRobot Select System?

The FDA product code for CryoRobot Select System is QUJ.

官方来源

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器械摘要

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