FDA 510(k)

米特克分流系統 GAV 2.0 及 SA 2.0 阀

K 號：K190174 · 2019-07-05

決定日期2019-07-05

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

Miethke Shunt System GAV 2.0 and SA 2.0 Valves is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2019-07-05 under 510(k) number K190174. 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 Miethke Shunt System GAV 2.0 and SA 2.0 Valves?

Miethke Shunt System GAV 2.0 and SA 2.0 Valves is a medical device that received FDA 510(k) clearance on 2019-07-05. The listed applicant is Aesculap, Inc.. The 510(k) number is K190174.

When did Miethke Shunt System GAV 2.0 and SA 2.0 Valves receive FDA 510(k) clearance?

Miethke Shunt System GAV 2.0 and SA 2.0 Valves received FDA 510(k) clearance on 2019-07-05, under 510(k) number K190174.

Who is the listed applicant for Miethke Shunt System GAV 2.0 and SA 2.0 Valves?

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 Miethke Shunt System GAV 2.0 and SA 2.0 Valves?

The FDA product code for Miethke Shunt System GAV 2.0 and SA 2.0 Valves 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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