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FDA 510(k)

Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)

K-Number: K160816 · 2016-09-21

ApplicantNexmed Technology Co., Ltd.
Decision Date2016-09-21
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) is a medical device manufactured by Nexmed Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-09-21 under approval number K160816. 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 Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)?

Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) is a medical device that received FDA 510(k) clearance on 2016-09-21. It is manufactured by Nexmed Technology Co., Ltd.. The 510(k) number is K160816.

When was Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) approved by the FDA?

Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) received FDA 510(k) clearance on 2016-09-21, under approval number K160816.

What company makes Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)?

Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) is manufactured by Nexmed Technology Co., Ltd..

What is the FDA product code for Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)?

The FDA product code for Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) 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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