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FDA 510(k)

THERMATREK IRIS-3 INFRARED IMAGING SYSTEM

K-Number: K982112 · 1998-08-20

ApplicantThermatrek, Inc.
Decision Date1998-08-20
Product CodeLHQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

THERMATREK IRIS-3 INFRARED IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Thermatrek, Inc.. It received FDA 510(k) clearance on 1998-08-20 under 510(k) number K982112. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMATREK IRIS-3 INFRARED IMAGING SYSTEM?

THERMATREK IRIS-3 INFRARED IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1998-08-20. The listed applicant is Thermatrek, Inc.. The 510(k) number is K982112.

When did THERMATREK IRIS-3 INFRARED IMAGING SYSTEM receive FDA 510(k) clearance?

THERMATREK IRIS-3 INFRARED IMAGING SYSTEM received FDA 510(k) clearance on 1998-08-20, under 510(k) number K982112.

Who is the listed applicant for THERMATREK IRIS-3 INFRARED IMAGING SYSTEM?

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

What is the FDA product code for THERMATREK IRIS-3 INFRARED IMAGING SYSTEM?

The FDA product code for THERMATREK IRIS-3 INFRARED IMAGING SYSTEM is LHQ.

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Related Devices (Code: LHQ)

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.

K253911Derma-2Neko Health ABK232462ThermPix Thermovisual CameraUsa Therm, Inc.K213650ThermPix Thermovisual CameraUsa Therm, Inc.K212965Smile-100 SystemNiramai Health Analytix Private LimitedK212412IRIS-XPMedicore Co., Ltd.K200999Thermidas IR System (ThIR-A615)Thermidas Americas, Inc.

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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