FDA 510(k)

真郁金香，真M.I.S.

K 號：K210816 · 2021-05-18

決定日期2021-05-18

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

True Tulip, True M.I.S. 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 2021-05-18 under 510(k) number K210816. 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, True M.I.S.?

True Tulip, True M.I.S. is a medical device that received FDA 510(k) clearance on 2021-05-18. The listed applicant is Innovative Surgical Designs, Inc.. The 510(k) number is K210816.

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

True Tulip, True M.I.S. received FDA 510(k) clearance on 2021-05-18, under 510(k) number K210816.

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

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, True M.I.S.?

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