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FDA 510(k)

LASERSAT CO2

K-Number: K904067 · 1990-11-07

ApplicantSatelec
Decision Date1990-11-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASERSAT CO2 is the device name listed in this FDA 510(k) record. The listed applicant is Satelec. It received FDA 510(k) clearance on 1990-11-07 under 510(k) number K904067. 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 LASERSAT CO2?

LASERSAT CO2 is a medical device that received FDA 510(k) clearance on 1990-11-07. The listed applicant is Satelec. The 510(k) number is K904067.

When did LASERSAT CO2 receive FDA 510(k) clearance?

LASERSAT CO2 received FDA 510(k) clearance on 1990-11-07, under 510(k) number K904067.

Who is the listed applicant for LASERSAT CO2?

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

What is the FDA product code for LASERSAT CO2?

The FDA product code for LASERSAT CO2 is GEX. This falls under the Gastroenterology category.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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