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FDA 510(k)

MILESMAN PREMIUM

K-Number: K073300 · 2007-12-04

ApplicantMilesman S.L.
Decision Date2007-12-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MILESMAN PREMIUM is the device name listed in this FDA 510(k) record. The listed applicant is Milesman S.L.. It received FDA 510(k) clearance on 2007-12-04 under 510(k) number K073300. 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 MILESMAN PREMIUM?

MILESMAN PREMIUM is a medical device that received FDA 510(k) clearance on 2007-12-04. The listed applicant is Milesman S.L.. The 510(k) number is K073300.

When did MILESMAN PREMIUM receive FDA 510(k) clearance?

MILESMAN PREMIUM received FDA 510(k) clearance on 2007-12-04, under 510(k) number K073300.

Who is the listed applicant for MILESMAN PREMIUM?

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

What is the FDA product code for MILESMAN PREMIUM?

The FDA product code for MILESMAN PREMIUM 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.

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