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FDA 510(k)

LMT-3000

K-Number: K172818 · 2018-03-07

ApplicantLameditech Co. , Ltd.
Decision Date2018-03-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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