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FDA 510(k)

COOLAN 300

K-Number: K030810 · 2004-05-05

ApplicantCoolanalgesia , Ltd.
Decision Date2004-05-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COOLAN 300 is the device name listed in this FDA 510(k) record. The listed applicant is Coolanalgesia , Ltd.. It received FDA 510(k) clearance on 2004-05-05 under 510(k) number K030810. 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 COOLAN 300?

COOLAN 300 is a medical device that received FDA 510(k) clearance on 2004-05-05. The listed applicant is Coolanalgesia , Ltd.. The 510(k) number is K030810.

When did COOLAN 300 receive FDA 510(k) clearance?

COOLAN 300 received FDA 510(k) clearance on 2004-05-05, under 510(k) number K030810.

Who is the listed applicant for COOLAN 300?

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

What is the FDA product code for COOLAN 300?

The FDA product code for COOLAN 300 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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