MT One Diamond
K-Number: K191942 · 2019-10-17
ApplicantM&T S.R.L.
Decision Date2019-10-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
MT One Diamond is a medical device manufactured by M&T S.R.L.. It received FDA 510(k) clearance on 2019-10-17 under approval number K191942. 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 Diamond?
MT One Diamond is a medical device that received FDA 510(k) clearance on 2019-10-17. It is manufactured by M&T S.R.L.. The 510(k) number is K191942.
When was MT One Diamond approved by the FDA?
MT One Diamond received FDA 510(k) clearance on 2019-10-17, under approval number K191942.
What company makes MT One Diamond?
MT One Diamond is manufactured by M&T S.R.L..
What is the FDA product code for MT One Diamond?
The FDA product code for MT One Diamond 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.