FDA 510(k)

ControlSeal 電極 (ELSB)

K 號：K223605 · 2022-12-30

申請人Coapt

決定日期2022-12-30

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

ControlSeal Electrode (ELSB) is the device name listed in this FDA 510(k) record. The listed applicant is Coapt. It received FDA 510(k) clearance on 2022-12-30 under 510(k) number K223605. 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 ControlSeal Electrode (ELSB)?

ControlSeal Electrode (ELSB) is a medical device that received FDA 510(k) clearance on 2022-12-30. The listed applicant is Coapt. The 510(k) number is K223605.

When did ControlSeal Electrode (ELSB) receive FDA 510(k) clearance?

ControlSeal Electrode (ELSB) received FDA 510(k) clearance on 2022-12-30, under 510(k) number K223605.

Who is the listed applicant for ControlSeal Electrode (ELSB)?

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

What is the FDA product code for ControlSeal Electrode (ELSB)?

The FDA product code for ControlSeal Electrode (ELSB) is GXY.

其他以 Coapt 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。

K223738Alpha Control Liner System (ACLS)

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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