FDA 510(k)

Everyway 緊急失禁刺激系統

K 號：K161349 · 2017-07-07

申請人Everyway Medical Instrument Co., Ltd.

決定日期2017-07-07

產品代碼KPI

諮詢委員會GU

決定相當於

器材摘要

Everyway Incontinence Stimulation System 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 2017-07-07 under 510(k) number K161349. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Everyway Incontinence Stimulation System?

Everyway Incontinence Stimulation System is a medical device that received FDA 510(k) clearance on 2017-07-07. The listed applicant is Everyway Medical Instrument Co., Ltd.. The 510(k) number is K161349.

When did Everyway Incontinence Stimulation System receive FDA 510(k) clearance?

Everyway Incontinence Stimulation System received FDA 510(k) clearance on 2017-07-07, under 510(k) number K161349.

Who is the listed applicant for Everyway Incontinence Stimulation System?

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 Incontinence Stimulation System?

The FDA product code for Everyway Incontinence Stimulation System is KPI.

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

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相關器械（代碼：KPI）

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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