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FDA 510(k)

BEAMAX

K-Number: K063249 · 2007-01-17

ApplicantMedic Sharplight , Ltd.
Decision Date2007-01-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BEAMAX is the device name listed in this FDA 510(k) record. The listed applicant is Medic Sharplight , Ltd.. It received FDA 510(k) clearance on 2007-01-17 under 510(k) number K063249. 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 BEAMAX?

BEAMAX is a medical device that received FDA 510(k) clearance on 2007-01-17. The listed applicant is Medic Sharplight , Ltd.. The 510(k) number is K063249.

When did BEAMAX receive FDA 510(k) clearance?

BEAMAX received FDA 510(k) clearance on 2007-01-17, under 510(k) number K063249.

Who is the listed applicant for BEAMAX?

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

What is the FDA product code for BEAMAX?

The FDA product code for BEAMAX 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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