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FDA 510(k)

INFRARED EAR THERMOMETER, MODEL IR-04MT

K-Number: K102934 · 2011-01-14

ApplicantVega Technologies, Inc.
Decision Date2011-01-14
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFRARED EAR THERMOMETER, MODEL IR-04MT is the device name listed in this FDA 510(k) record. The listed applicant is Vega Technologies, Inc.. It received FDA 510(k) clearance on 2011-01-14 under 510(k) number K102934. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFRARED EAR THERMOMETER, MODEL IR-04MT?

INFRARED EAR THERMOMETER, MODEL IR-04MT is a medical device that received FDA 510(k) clearance on 2011-01-14. The listed applicant is Vega Technologies, Inc.. The 510(k) number is K102934.

When did INFRARED EAR THERMOMETER, MODEL IR-04MT receive FDA 510(k) clearance?

INFRARED EAR THERMOMETER, MODEL IR-04MT received FDA 510(k) clearance on 2011-01-14, under 510(k) number K102934.

Who is the listed applicant for INFRARED EAR THERMOMETER, MODEL IR-04MT?

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

What is the FDA product code for INFRARED EAR THERMOMETER, MODEL IR-04MT?

The FDA product code for INFRARED EAR THERMOMETER, MODEL IR-04MT is FLL.

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Other records listing Vega Technologies, Inc. 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.

K102625VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03K102626VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01K041516DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9K031413VIGORMIST COMPRESSOR NEBULIZERK002831VEGA ULTRASONIC NEBULIZER

Related Devices (Code: FLL)

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.

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Official Source

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