MT ONE
K-Number: K172413 · 2017-10-06
ApplicantM&T S.R.L.
Decision Date2017-10-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
MT ONE is a medical device manufactured by M&T S.R.L.. It received FDA 510(k) clearance on 2017-10-06 under approval number K172413. 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 MT ONE?
MT ONE is a medical device that received FDA 510(k) clearance on 2017-10-06. It is manufactured by M&T S.R.L.. The 510(k) number is K172413.
When was MT ONE approved by the FDA?
MT ONE received FDA 510(k) clearance on 2017-10-06, under approval number K172413.
What company makes MT ONE?
MT ONE is manufactured by M&T S.R.L..
What is the FDA product code for MT ONE?
The FDA product code for MT ONE is GEX. This falls under the Gastroenterology category.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.