FDA 510(k)

U-Lite PRO

K 號：K232285 · 2024-01-11

決定日期2024-01-11

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

U-Lite PRO is the device name listed in this FDA 510(k) record. The listed applicant is Sonoscanner Sarl. It received FDA 510(k) clearance on 2024-01-11 under 510(k) number K232285. 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 PRO?

U-Lite PRO is a medical device that received FDA 510(k) clearance on 2024-01-11. The listed applicant is Sonoscanner Sarl. The 510(k) number is K232285.

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

U-Lite PRO received FDA 510(k) clearance on 2024-01-11, under 510(k) number K232285.

Who is the listed applicant for U-Lite PRO?

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

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

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

相關器械（代碼：IYN）

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官方來源

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