FDA 510(k)

LMT-3000

K 號：K172818 · 2018-03-07

決定日期2018-03-07

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

LMT-3000 is the device name listed in this FDA 510(k) record. The listed applicant is Lameditech Co. , Ltd.. It received FDA 510(k) clearance on 2018-03-07 under 510(k) number K172818. 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 LMT-3000?

LMT-3000 is a medical device that received FDA 510(k) clearance on 2018-03-07. The listed applicant is Lameditech Co. , Ltd.. The 510(k) number is K172818.

When did LMT-3000 receive FDA 510(k) clearance?

LMT-3000 received FDA 510(k) clearance on 2018-03-07, under 510(k) number K172818.

Who is the listed applicant for LMT-3000?

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

What is the FDA product code for LMT-3000?

The FDA product code for LMT-3000 is GEX. This falls under the Gastroenterology category.

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