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FDA 510(k)

XTRAC XL, MODEL AL8000

K-Number: K041943 · 2004-10-14

ApplicantPhoto Medex, Inc.
Decision Date2004-10-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

XTRAC XL, MODEL AL8000 is the device name listed in this FDA 510(k) record. The listed applicant is Photo Medex, Inc.. It received FDA 510(k) clearance on 2004-10-14 under 510(k) number K041943. 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 XTRAC XL, MODEL AL8000?

XTRAC XL, MODEL AL8000 is a medical device that received FDA 510(k) clearance on 2004-10-14. The listed applicant is Photo Medex, Inc.. The 510(k) number is K041943.

When did XTRAC XL, MODEL AL8000 receive FDA 510(k) clearance?

XTRAC XL, MODEL AL8000 received FDA 510(k) clearance on 2004-10-14, under 510(k) number K041943.

Who is the listed applicant for XTRAC XL, MODEL AL8000?

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

What is the FDA product code for XTRAC XL, MODEL AL8000?

The FDA product code for XTRAC XL, MODEL AL8000 is GEX. This falls under the Gastroenterology category.

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Other records listing Photo Medex, Inc. as applicant

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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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