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FDA 510(k)

Mobius3D

K号: K153014 · 2016-04-29

决定日期2016-04-29
产品代码IYE
咨询委员会RA
决定实质等同

器械摘要

Mobius3D is the device name listed in this FDA 510(k) record. The listed applicant is Mobius Medical Systems, LP. It received FDA 510(k) clearance on 2016-04-29 under 510(k) number K153014. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Mobius3D?

Mobius3D is a medical device that received FDA 510(k) clearance on 2016-04-29. The listed applicant is Mobius Medical Systems, LP. The 510(k) number is K153014.

When did Mobius3D receive FDA 510(k) clearance?

Mobius3D received FDA 510(k) clearance on 2016-04-29, under 510(k) number K153014.

Who is the listed applicant for Mobius3D?

The FDA 510(k) record lists Mobius Medical Systems, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mobius3D?

The FDA product code for Mobius3D is IYE.

相关临床试验

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相关器械(代码:IYE)

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