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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is M&T S.R.L.. It received FDA 510(k) clearance on 2019-10-17 under 510(k) 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. The listed applicant is M&T S.R.L.. The 510(k) number is K191942.

When did MT One Diamond receive FDA 510(k) clearance?

MT One Diamond received FDA 510(k) clearance on 2019-10-17, under 510(k) number K191942.

Who is the listed applicant for MT One Diamond?

The FDA 510(k) record lists M&T S.R.L. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing M&T S.R.L. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240604MTONE EVO (MTONE EVO)K192856MT OneK172413MT ONE

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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