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FDA 510(k)

IR VIEWER

K-Number: K042679 · 2004-12-10

ApplicantInfrared Imaging Systems, Inc.
Decision Date2004-12-10
Product CodeKZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IR VIEWER is the device name listed in this FDA 510(k) record. The listed applicant is Infrared Imaging Systems, Inc.. It received FDA 510(k) clearance on 2004-12-10 under 510(k) number K042679. The device is classified under product code KZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IR VIEWER?

IR VIEWER is a medical device that received FDA 510(k) clearance on 2004-12-10. The listed applicant is Infrared Imaging Systems, Inc.. The 510(k) number is K042679.

When did IR VIEWER receive FDA 510(k) clearance?

IR VIEWER received FDA 510(k) clearance on 2004-12-10, under 510(k) number K042679.

Who is the listed applicant for IR VIEWER?

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

What is the FDA product code for IR VIEWER?

The FDA product code for IR VIEWER is KZA.

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Related Devices (Code: KZA)

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.

K152088IV-eyeNovarix LimitedK101838VTS1000Vuetek Scientific, LLCK982612ESP7 VENOUS IMAGEIronmaster, Inc.K780884HYPO-GRIPHarco ProductsK780883E-Z-JECTORHarco Products

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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