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FDA 510(k)

EasyStep

K号: K160813 · 2016-07-26

申请人Stryker GmbH
决定日期2016-07-26
产品代码JDR
咨询委员会OR
决定Substantially Equivalent

器械摘要

EasyStep is the device name listed in this FDA 510(k) record. The listed applicant is Stryker GmbH. It received FDA 510(k) clearance on 2016-07-26 under 510(k) number K160813. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EasyStep?

EasyStep is a medical device that received FDA 510(k) clearance on 2016-07-26. The listed applicant is Stryker GmbH. The 510(k) number is K160813.

When did EasyStep receive FDA 510(k) clearance?

EasyStep received FDA 510(k) clearance on 2016-07-26, under 510(k) number K160813.

Who is the listed applicant for EasyStep?

The FDA 510(k) record lists Stryker GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EasyStep?

The FDA product code for EasyStep is JDR.

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列明Stryker GmbH为申报人的其他记录

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相关器械(代码:JDR)

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官方来源

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