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FDA 510(k)

MTONE EVO (MTONE EVO)

K-Number: K240604 · 2024-09-20

ApplicantM&T S.R.L.
Decision Date2024-09-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MTONE EVO (MTONE EVO) 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 2024-09-20 under 510(k) number K240604. 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 MTONE EVO (MTONE EVO)?

MTONE EVO (MTONE EVO) is a medical device that received FDA 510(k) clearance on 2024-09-20. The listed applicant is M&T S.R.L.. The 510(k) number is K240604.

When did MTONE EVO (MTONE EVO) receive FDA 510(k) clearance?

MTONE EVO (MTONE EVO) received FDA 510(k) clearance on 2024-09-20, under 510(k) number K240604.

Who is the listed applicant for MTONE EVO (MTONE EVO)?

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 MTONE EVO (MTONE EVO)?

The FDA product code for MTONE EVO (MTONE EVO) is GEX. This falls under the Gastroenterology category.

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

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Related Devices (Code: GEX)

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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.

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