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FDA 510(k)

THERMATREK IRIS-IV INFRARED IMAGING SYSTEM

K-Number: K030165 · 2003-04-16

ApplicantThermatrek
Decision Date2003-04-16
Product CodeLHQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

THERMATREK IRIS-IV INFRARED IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Thermatrek. It received FDA 510(k) clearance on 2003-04-16 under 510(k) number K030165. 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-IV INFRARED IMAGING SYSTEM?

THERMATREK IRIS-IV INFRARED IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2003-04-16. The listed applicant is Thermatrek. The 510(k) number is K030165.

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

THERMATREK IRIS-IV INFRARED IMAGING SYSTEM received FDA 510(k) clearance on 2003-04-16, under 510(k) number K030165.

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

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

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

The FDA product code for THERMATREK IRIS-IV 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

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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