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FDA 510(k)

規劃3D

K 號：K181112 · 2018-11-26

申請人Orchestrate 3D
決定日期2018-11-26
產品代碼PNN
諮詢委員會DE
決定相當於

器材摘要

Orchestrate 3D is the device name listed in this FDA 510(k) record. The listed applicant is Orchestrate 3D. It received FDA 510(k) clearance on 2018-11-26 under 510(k) number K181112. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Orchestrate 3D?

Orchestrate 3D is a medical device that received FDA 510(k) clearance on 2018-11-26. The listed applicant is Orchestrate 3D. The 510(k) number is K181112.

When did Orchestrate 3D receive FDA 510(k) clearance?

Orchestrate 3D received FDA 510(k) clearance on 2018-11-26, under 510(k) number K181112.

Who is the listed applicant for Orchestrate 3D?

The FDA 510(k) record lists Orchestrate 3D as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Orchestrate 3D?

The FDA product code for Orchestrate 3D is PNN.

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