FDA 510(k)

MIIN

K-Number: K193266 · 2021-01-22

Decision Date2021-01-22

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MIIN is a medical device manufactured by Medico USA, Inc.. It received FDA 510(k) clearance on 2021-01-22 under approval number K193266. 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 MIIN?

MIIN is a medical device that received FDA 510(k) clearance on 2021-01-22. It is manufactured by Medico USA, Inc.. The 510(k) number is K193266.

When was MIIN approved by the FDA?

MIIN received FDA 510(k) clearance on 2021-01-22, under approval number K193266.

What company makes MIIN?

MIIN is manufactured by Medico USA, Inc..

What is the FDA product code for MIIN?

The FDA product code for MIIN 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.