FDA 510(k)

Navi e/Navi s/Navi X 診斷超音波系統

K 號：K180461 · 2018-05-09

申請人Shenzhen Wisonic Medical Technology Co. , Ltd.

決定日期2018-05-09

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Navi e/Navi s/Navi X Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Wisonic Medical Technology Co. , Ltd.. It received FDA 510(k) clearance on 2018-05-09 under 510(k) number K180461. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Navi e/Navi s/Navi X Diagnostic Ultrasound System?

Navi e/Navi s/Navi X Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2018-05-09. The listed applicant is Shenzhen Wisonic Medical Technology Co. , Ltd.. The 510(k) number is K180461.

When did Navi e/Navi s/Navi X Diagnostic Ultrasound System receive FDA 510(k) clearance?

Navi e/Navi s/Navi X Diagnostic Ultrasound System received FDA 510(k) clearance on 2018-05-09, under 510(k) number K180461.

Who is the listed applicant for Navi e/Navi s/Navi X Diagnostic Ultrasound System?

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

What is the FDA product code for Navi e/Navi s/Navi X Diagnostic Ultrasound System?

The FDA product code for Navi e/Navi s/Navi X Diagnostic Ultrasound System is IYN.

其他以 Shenzhen Wisonic Medical Technology Co. , Ltd. 為申請人之記錄

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相關器械（代碼：IYN）

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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