FDA 510(k)

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

Numéro K : K160816 · 2016-09-21

Date de décision2016-09-21

Code produitFLL

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) is the device name listed in this FDA 510(k) record. The listed applicant is Nexmed Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-09-21 under 510(k) number K160816. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Nexmed Technology Co., Ltd.. The 510(k) number is K160816.

When did Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) receive FDA 510(k) clearance?

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 510(k) number K160816.

Who is the listed applicant for Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)?

The FDA 510(k) record lists Nexmed Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Dispositifs connexes (Code : FLL)

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Source officielle

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