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FDA 510(k)

元素系統配備IBT電極

K 號：K173571 · 2018-03-21

申請人Infinite Biomedical Technologies, LLC
決定日期2018-03-21
產品代碼GXY
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

Element System with IBT Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Infinite Biomedical Technologies, LLC. It received FDA 510(k) clearance on 2018-03-21 under 510(k) number K173571. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Element System with IBT Electrodes?

Element System with IBT Electrodes is a medical device that received FDA 510(k) clearance on 2018-03-21. The listed applicant is Infinite Biomedical Technologies, LLC. The 510(k) number is K173571.

When did Element System with IBT Electrodes receive FDA 510(k) clearance?

Element System with IBT Electrodes received FDA 510(k) clearance on 2018-03-21, under 510(k) number K173571.

Who is the listed applicant for Element System with IBT Electrodes?

The FDA 510(k) record lists Infinite Biomedical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Element System with IBT Electrodes?

The FDA product code for Element System with IBT Electrodes is GXY.

相關臨床試驗

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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其他以 Infinite Biomedical Technologies, LLC 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。

K240884Glide (91000-GL-X)K182112感知系統配備IBT電極

相關器械（代碼：GXY）

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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