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FDA 510(k)

S系列電極 / 型號 S55105、S80120、SG4040、SG4368、SG50D、SG5050、SG5075、SG50100、SG5795、SG60147、SG7090 及 SG75D

K 號:K173186 · 2018-02-28

決定日期2018-02-28
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

S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D is the device name listed in this FDA 510(k) record. The listed applicant is Everyway Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2018-02-28 under 510(k) number K173186. 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 S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D?

S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D is a medical device that received FDA 510(k) clearance on 2018-02-28. The listed applicant is Everyway Medical Instruments Co.,Ltd. The 510(k) number is K173186.

When did S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D receive FDA 510(k) clearance?

S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D received FDA 510(k) clearance on 2018-02-28, under 510(k) number K173186.

Who is the listed applicant for S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D?

The FDA 510(k) record lists Everyway Medical Instruments Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D?

The FDA product code for S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D is GXY.

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其他以 Everyway Medical Instruments Co.,Ltd 為申請人之記錄

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相關器械(代碼:GXY)

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官方來源

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