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FDA 510(k)

Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)

K-Number: K210014 · 2021-06-04

ApplicantGuandong Genial Technology Co., Limited
Decision Date2021-06-04
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) is a medical device manufactured by Guandong Genial Technology Co., Limited. It received FDA 510(k) clearance on 2021-06-04 under approval number K210014. 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 Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)?

Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) is a medical device that received FDA 510(k) clearance on 2021-06-04. It is manufactured by Guandong Genial Technology Co., Limited. The 510(k) number is K210014.

When was Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) approved by the FDA?

Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) received FDA 510(k) clearance on 2021-06-04, under approval number K210014.

What company makes Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)?

Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) is manufactured by Guandong Genial Technology Co., Limited.

What is the FDA product code for Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)?

The FDA product code for Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) is FLL.

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Related Devices (Code: FLL)

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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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