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FDA 510(k)

IMALUX OCT PROBE GUIDE

K-Number: K041077 · 2004-06-25

ApplicantImalux Corporation
Decision Date2004-06-25
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IMALUX OCT PROBE GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Imalux Corporation. It received FDA 510(k) clearance on 2004-06-25 under 510(k) number K041077. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMALUX OCT PROBE GUIDE?

IMALUX OCT PROBE GUIDE is a medical device that received FDA 510(k) clearance on 2004-06-25. The listed applicant is Imalux Corporation. The 510(k) number is K041077.

When did IMALUX OCT PROBE GUIDE receive FDA 510(k) clearance?

IMALUX OCT PROBE GUIDE received FDA 510(k) clearance on 2004-06-25, under 510(k) number K041077.

Who is the listed applicant for IMALUX OCT PROBE GUIDE?

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

What is the FDA product code for IMALUX OCT PROBE GUIDE?

The FDA product code for IMALUX OCT PROBE GUIDE is KKX.

Related Clinical Trials

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Other records listing Imalux Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K042894IMALUX NIRIS IMAGING SYSTEM

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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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