FDA 510(k)

StrataMR 過濾器和分流器

K 號：K152700 · 2016-04-07

決定日期2016-04-07

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

StrataMR Valves and Shunts is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Neurosurgery. It received FDA 510(k) clearance on 2016-04-07 under 510(k) number K152700. 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 StrataMR Valves and Shunts?

StrataMR Valves and Shunts is a medical device that received FDA 510(k) clearance on 2016-04-07. The listed applicant is Medtronic Neurosurgery. The 510(k) number is K152700.

When did StrataMR Valves and Shunts receive FDA 510(k) clearance?

StrataMR Valves and Shunts received FDA 510(k) clearance on 2016-04-07, under 510(k) number K152700.

Who is the listed applicant for StrataMR Valves and Shunts?

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

What is the FDA product code for StrataMR Valves and Shunts?

The FDA product code for StrataMR Valves and Shunts is JXG.

其他以 Medtronic Neurosurgery 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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