FDA 510(k)

Omnimax S3, Omnimax S4

K 號：K233304 · 2023-12-22

決定日期2023-12-22

產品代碼GEX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Omnimax S3, Omnimax S4 is the device name listed in this FDA 510(k) record. The listed applicant is Sharplight Technologies, Ltd.. It received FDA 510(k) clearance on 2023-12-22 under 510(k) number K233304. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Omnimax S3, Omnimax S4?

Omnimax S3, Omnimax S4 is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is Sharplight Technologies, Ltd.. The 510(k) number is K233304.

When did Omnimax S3, Omnimax S4 receive FDA 510(k) clearance?

Omnimax S3, Omnimax S4 received FDA 510(k) clearance on 2023-12-22, under 510(k) number K233304.

Who is the listed applicant for Omnimax S3, Omnimax S4?

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

What is the FDA product code for Omnimax S3, Omnimax S4?

The FDA product code for Omnimax S3, Omnimax S4 is GEX. This falls under the Gastroenterology category.

其他以 Sharplight Technologies, Ltd. 為申請人之記錄

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