FDA 510(k)

真郁金香系統，真M.I.S.系統

K 號：K201780 · 2020-07-22

決定日期2020-07-22

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

True Tulip System, True M.I.S. System is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Surgical Designs, Inc.. It received FDA 510(k) clearance on 2020-07-22 under 510(k) number K201780. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the True Tulip System, True M.I.S. System?

True Tulip System, True M.I.S. System is a medical device that received FDA 510(k) clearance on 2020-07-22. The listed applicant is Innovative Surgical Designs, Inc.. The 510(k) number is K201780.

When did True Tulip System, True M.I.S. System receive FDA 510(k) clearance?

True Tulip System, True M.I.S. System received FDA 510(k) clearance on 2020-07-22, under 510(k) number K201780.

Who is the listed applicant for True Tulip System, True M.I.S. System?

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

What is the FDA product code for True Tulip System, True M.I.S. System?

The FDA product code for True Tulip System, True M.I.S. System is NKB.

其他以 Innovative Surgical Designs, Inc. 為申請人之記錄

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相關器械（代碼：NKB）

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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