Decision Date2021-12-08
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Infrared forehead thermometer LD-FT-100B is a medical device manufactured by Honsun (Nantong) Co., Ltd.. It received FDA 510(k) clearance on 2021-12-08 under approval number K211629. 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 LD-FT-100B?
Infrared forehead thermometer LD-FT-100B is a medical device that received FDA 510(k) clearance on 2021-12-08. It is manufactured by Honsun (Nantong) Co., Ltd.. The 510(k) number is K211629.
When was Infrared forehead thermometer LD-FT-100B approved by the FDA?
Infrared forehead thermometer LD-FT-100B received FDA 510(k) clearance on 2021-12-08, under approval number K211629.
What company makes Infrared forehead thermometer LD-FT-100B?
Infrared forehead thermometer LD-FT-100B is manufactured by Honsun (Nantong) Co., Ltd..
What is the FDA product code for Infrared forehead thermometer LD-FT-100B?
The FDA product code for Infrared forehead thermometer LD-FT-100B is FLL.
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Related Devices (Code: FLL)
K160306Cloud Smart ThermometerGuangzhou Bosma Technology Co, Ltd.
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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.
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Official Source
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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.