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FDA 510(k)

GENEMED YAG 1000 MEDICAL LASER

K-Number: K943479 · 1994-09-29

ApplicantGenemed, Inc.
Decision Date1994-09-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GENEMED YAG 1000 MEDICAL LASER is the device name listed in this FDA 510(k) record. The listed applicant is Genemed, Inc.. It received FDA 510(k) clearance on 1994-09-29 under 510(k) number K943479. 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 GENEMED YAG 1000 MEDICAL LASER?

GENEMED YAG 1000 MEDICAL LASER is a medical device that received FDA 510(k) clearance on 1994-09-29. The listed applicant is Genemed, Inc.. The 510(k) number is K943479.

When did GENEMED YAG 1000 MEDICAL LASER receive FDA 510(k) clearance?

GENEMED YAG 1000 MEDICAL LASER received FDA 510(k) clearance on 1994-09-29, under 510(k) number K943479.

Who is the listed applicant for GENEMED YAG 1000 MEDICAL LASER?

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

What is the FDA product code for GENEMED YAG 1000 MEDICAL LASER?

The FDA product code for GENEMED YAG 1000 MEDICAL LASER 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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