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FDA 510(k)

maxmorespine雙極電極

K 號:K211173 · 2022-06-23

決定日期2022-06-23
產品代碼GEI
諮詢委員會SU 請提供完整的描述文本,以便我進行翻譯。
決定相當於

器材摘要

maxmorespine Bipolar Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Hoogland Spine Products, GmbH. It received FDA 510(k) clearance on 2022-06-23 under 510(k) number K211173. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the maxmorespine Bipolar Electrodes?

maxmorespine Bipolar Electrodes is a medical device that received FDA 510(k) clearance on 2022-06-23. The listed applicant is Hoogland Spine Products, GmbH. The 510(k) number is K211173.

When did maxmorespine Bipolar Electrodes receive FDA 510(k) clearance?

maxmorespine Bipolar Electrodes received FDA 510(k) clearance on 2022-06-23, under 510(k) number K211173.

Who is the listed applicant for maxmorespine Bipolar Electrodes?

The FDA 510(k) record lists Hoogland Spine Products, GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for maxmorespine Bipolar Electrodes?

The FDA product code for maxmorespine Bipolar Electrodes is GEI.

相關臨床試驗

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相關器械(代碼:GEI)

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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