FDA 510(k)

ULab Systems uDesign 軟體

K 號：K200772 · 2020-06-23

決定日期2020-06-23

產品代碼PNN

諮詢委員會DE

決定相當於

器材摘要

ULab Systems uDesign Software is the device name listed in this FDA 510(k) record. The listed applicant is Ulab Systems, Inc.. It received FDA 510(k) clearance on 2020-06-23 under 510(k) number K200772. 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 ULab Systems uDesign Software?

ULab Systems uDesign Software is a medical device that received FDA 510(k) clearance on 2020-06-23. The listed applicant is Ulab Systems, Inc.. The 510(k) number is K200772.

When did ULab Systems uDesign Software receive FDA 510(k) clearance?

ULab Systems uDesign Software received FDA 510(k) clearance on 2020-06-23, under 510(k) number K200772.

Who is the listed applicant for ULab Systems uDesign Software?

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

What is the FDA product code for ULab Systems uDesign Software?

The FDA product code for ULab Systems uDesign Software is PNN.

其他以 Ulab Systems, Inc. 為申請人之記錄

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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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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