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FDA 510(k)

一次性快接電極

K 號:K172703 · 2017-11-13

申請人Embla Systems
決定日期2017-11-13
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

Disposable Snap Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Embla Systems. It received FDA 510(k) clearance on 2017-11-13 under 510(k) number K172703. 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 Disposable Snap Electrode?

Disposable Snap Electrode is a medical device that received FDA 510(k) clearance on 2017-11-13. The listed applicant is Embla Systems. The 510(k) number is K172703.

When did Disposable Snap Electrode receive FDA 510(k) clearance?

Disposable Snap Electrode received FDA 510(k) clearance on 2017-11-13, under 510(k) number K172703.

Who is the listed applicant for Disposable Snap Electrode?

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

What is the FDA product code for Disposable Snap Electrode?

The FDA product code for Disposable Snap Electrode is GXY.

相關臨床試驗

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其他以 Embla Systems 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。

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。

官方來源

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