FDA 510(k)

Anchor Bolt 作為深度電極的配件

K 號：K223276 · 2023-05-18

申請人Ad-Tech Medical Instrument Corporation

決定日期2023-05-18

產品代碼GZL

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

Anchor Bolts as Accessories to Depth Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Ad-Tech Medical Instrument Corporation. It received FDA 510(k) clearance on 2023-05-18 under 510(k) number K223276. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Anchor Bolts as Accessories to Depth Electrodes?

Anchor Bolts as Accessories to Depth Electrodes is a medical device that received FDA 510(k) clearance on 2023-05-18. The listed applicant is Ad-Tech Medical Instrument Corporation. The 510(k) number is K223276.

When did Anchor Bolts as Accessories to Depth Electrodes receive FDA 510(k) clearance?

Anchor Bolts as Accessories to Depth Electrodes received FDA 510(k) clearance on 2023-05-18, under 510(k) number K223276.

Who is the listed applicant for Anchor Bolts as Accessories to Depth Electrodes?

The FDA 510(k) record lists Ad-Tech Medical Instrument Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anchor Bolts as Accessories to Depth Electrodes?

The FDA product code for Anchor Bolts as Accessories to Depth Electrodes is GZL.

其他以 Ad-Tech Medical Instrument Corporation 為申請人之記錄

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。

K223269斯潘塞探測深度電極 K191186硬膜下條/手術中分離電極、硬膜下網/手術中網狀電極、雙面橫斷半球硬膜下電極、多條和縫隙網狀硬膜下電極、手術中定位網狀硬膜下電極 K181544Anchor Bolt（作為深度電極的配件）K170442頭蓋骨钻頭及配件 K163355深度電極，卵圓孔深度電極，馬可-微深度電極，斯潘塞探針深度電極 K152769FREMAP 電極

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相關器械（代碼：GZL）

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。

官方來源

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