FDA 510(k)

U-Lite EXP

K 號：K171164 · 2017-08-03

決定日期2017-08-03

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

U-Lite EXP is the device name listed in this FDA 510(k) record. The listed applicant is Sonoscanner. It received FDA 510(k) clearance on 2017-08-03 under 510(k) number K171164. 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 U-Lite EXP?

U-Lite EXP is a medical device that received FDA 510(k) clearance on 2017-08-03. The listed applicant is Sonoscanner. The 510(k) number is K171164.

When did U-Lite EXP receive FDA 510(k) clearance?

U-Lite EXP received FDA 510(k) clearance on 2017-08-03, under 510(k) number K171164.

Who is the listed applicant for U-Lite EXP?

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

What is the FDA product code for U-Lite EXP?

The FDA product code for U-Lite EXP is IYN.

其他以 Sonoscanner 為申請人之記錄

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K201988T-Lite

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。

官方來源

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