FDA 510(k)

M. 藍色調節閘系統

K 號：K192266 · 2019-11-21

決定日期2019-11-21

產品代碼JXG

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

M. Blue Adjustable Shunt System is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2019-11-21 under 510(k) number K192266. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the M. Blue Adjustable Shunt System?

M. Blue Adjustable Shunt System is a medical device that received FDA 510(k) clearance on 2019-11-21. The listed applicant is Aesculap, Inc.. The 510(k) number is K192266.

When did M. Blue Adjustable Shunt System receive FDA 510(k) clearance?

M. Blue Adjustable Shunt System received FDA 510(k) clearance on 2019-11-21, under 510(k) number K192266.

Who is the listed applicant for M. Blue Adjustable Shunt System?

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

What is the FDA product code for M. Blue Adjustable Shunt System?

The FDA product code for M. Blue Adjustable Shunt System is JXG.

其他以 Aesculap, Inc. 為申請人之記錄

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相關器械（代碼：JXG）

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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