FDA 510(k)

正骨科系統

K 號：K180941 · 2018-10-17

決定日期2018-10-17

產品代碼PNN

諮詢委員會DE

決定相當於

器材摘要

Ortho System is the device name listed in this FDA 510(k) record. The listed applicant is 3Shape A/S. It received FDA 510(k) clearance on 2018-10-17 under 510(k) number K180941. 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 Ortho System?

Ortho System is a medical device that received FDA 510(k) clearance on 2018-10-17. The listed applicant is 3Shape A/S. The 510(k) number is K180941.

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

Ortho System received FDA 510(k) clearance on 2018-10-17, under 510(k) number K180941.

Who is the listed applicant for Ortho System?

The FDA 510(k) record lists 3Shape A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ortho System?

The FDA product code for Ortho System is PNN.

其他以 3Shape A/S 為申請人之記錄

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相關器械（代碼：PNN）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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