FDA 510(k)

Everyway OTC EMS，型號 EV-805

K 號：K162744 · 2017-08-03

申請人Everyway Medical Instrument Co., Ltd.

決定日期2017-08-03

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

Everyway OTC EMS, Model EV-805 is the device name listed in this FDA 510(k) record. The listed applicant is Everyway Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2017-08-03 under 510(k) number K162744. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Everyway OTC EMS, Model EV-805?

Everyway OTC EMS, Model EV-805 is a medical device that received FDA 510(k) clearance on 2017-08-03. The listed applicant is Everyway Medical Instrument Co., Ltd.. The 510(k) number is K162744.

When did Everyway OTC EMS, Model EV-805 receive FDA 510(k) clearance?

Everyway OTC EMS, Model EV-805 received FDA 510(k) clearance on 2017-08-03, under 510(k) number K162744.

Who is the listed applicant for Everyway OTC EMS, Model EV-805?

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

What is the FDA product code for Everyway OTC EMS, Model EV-805?

The FDA product code for Everyway OTC EMS, Model EV-805 is NGX.

其他以 Everyway Medical Instrument Co., Ltd. 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。

K161349Everyway 緊急失禁刺激系統

相關器械（代碼：NGX）

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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官方來源

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