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FDA 510(k)

Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT)

K-Number: K152640 · 2016-03-28

ApplicantFudakang Industries Co., Ltd.
Decision Date2016-03-28
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT) is a medical device manufactured by Fudakang Industries Co., Ltd.. It received FDA 510(k) clearance on 2016-03-28 under approval number K152640. 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 (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT)?

Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT) is a medical device that received FDA 510(k) clearance on 2016-03-28. It is manufactured by Fudakang Industries Co., Ltd.. The 510(k) number is K152640.

When was Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT) approved by the FDA?

Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT) received FDA 510(k) clearance on 2016-03-28, under approval number K152640.

What company makes Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT)?

Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT) is manufactured by Fudakang Industries Co., Ltd..

What is the FDA product code for Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT)?

The FDA product code for Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT) is FLL.

Related Devices (Code: FLL)

K160306Cloud Smart ThermometerGuangzhou Bosma Technology Co, Ltd. K161728Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1Microfile Intellectual Property GmbH K161735Non-contact Forehead ThermometerShenzhen Dongdixin Technology Co., Ltd. K160816Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)Nexmed Technology Co., Ltd. K161211Digital ThermometerBiocare Asia Corporation , Ltd. K160802Infrared Forehead Thermometer, FT-100AHangzhou Universal Electronic Co., Ltd.

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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