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FDA 510(k)

MYTHOS 500

K-Number: K030805 · 2003-05-21

ApplicantMsq (M2) , Ltd.
Decision Date2003-05-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MYTHOS 500 is the device name listed in this FDA 510(k) record. The listed applicant is Msq (M2) , Ltd.. It received FDA 510(k) clearance on 2003-05-21 under 510(k) number K030805. 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 MYTHOS 500?

MYTHOS 500 is a medical device that received FDA 510(k) clearance on 2003-05-21. The listed applicant is Msq (M2) , Ltd.. The 510(k) number is K030805.

When did MYTHOS 500 receive FDA 510(k) clearance?

MYTHOS 500 received FDA 510(k) clearance on 2003-05-21, under 510(k) number K030805.

Who is the listed applicant for MYTHOS 500?

The FDA 510(k) record lists Msq (M2) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MYTHOS 500?

The FDA product code for MYTHOS 500 is GEX. This falls under the Gastroenterology category.

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Other records listing Msq (M2) , Ltd. as applicant

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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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