FDA 510(k)

守護者骨孔蓋系統，守護者螺釘，骨孔蓋

K 號：K152342 · 2016-06-09

決定日期2016-06-09

產品代碼GXR

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

Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2016-06-09 under 510(k) number K152342. The device is classified under product code GXR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover?

Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover is a medical device that received FDA 510(k) clearance on 2016-06-09. The listed applicant is St Jude Medical. The 510(k) number is K152342.

When did Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover receive FDA 510(k) clearance?

Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover received FDA 510(k) clearance on 2016-06-09, under 510(k) number K152342.

Who is the listed applicant for Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover?

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

What is the FDA product code for Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover?

The FDA product code for Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover is GXR.

其他以 St Jude Medical 為申請人之記錄

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相關器械（代碼：GXR）

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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