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FDA 510(k)

CryoVizion 系统

K号: K183485 · 2019-08-28

决定日期2019-08-28
产品代码LDK
决定实质等同

器械摘要

CryoVizion System is the device name listed in this FDA 510(k) record. The listed applicant is Cryos Technologies, Inc.. It received FDA 510(k) clearance on 2019-08-28 under 510(k) number K183485. The device is classified under product code LDK. FDA Decision: Substantially Equivalent.

常见问题

What is the CryoVizion System?

CryoVizion System is a medical device that received FDA 510(k) clearance on 2019-08-28. The listed applicant is Cryos Technologies, Inc.. The 510(k) number is K183485.

When did CryoVizion System receive FDA 510(k) clearance?

CryoVizion System received FDA 510(k) clearance on 2019-08-28, under 510(k) number K183485.

Who is the listed applicant for CryoVizion System?

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

What is the FDA product code for CryoVizion System?

The FDA product code for CryoVizion System is LDK.

相关临床试验

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相关器械(代码:LDK)

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