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FDA 510(k)

HILUX LEDMAX 3

K-Number: K040956 · 2004-06-14

ApplicantFirst Medical Infection Control Associates, Inc.
Decision Date2004-06-14
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HILUX LEDMAX 3 is the device name listed in this FDA 510(k) record. The listed applicant is First Medical Infection Control Associates, Inc.. It received FDA 510(k) clearance on 2004-06-14 under 510(k) number K040956. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HILUX LEDMAX 3?

HILUX LEDMAX 3 is a medical device that received FDA 510(k) clearance on 2004-06-14. The listed applicant is First Medical Infection Control Associates, Inc.. The 510(k) number is K040956.

When did HILUX LEDMAX 3 receive FDA 510(k) clearance?

HILUX LEDMAX 3 received FDA 510(k) clearance on 2004-06-14, under 510(k) number K040956.

Who is the listed applicant for HILUX LEDMAX 3?

The FDA 510(k) record lists First Medical Infection Control Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HILUX LEDMAX 3?

The FDA product code for HILUX LEDMAX 3 is EBZ.

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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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