Infra-red forehead thermometer
K-Number: K160999 · 2016-08-01
Decision Date2016-08-01
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Infra-red forehead thermometer is a medical device manufactured by Hangzhou Hua'An Medical&Health Instruments Co.,Ltd. It received FDA 510(k) clearance on 2016-08-01 under approval number K160999. 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 Infra-red forehead thermometer?
Infra-red forehead thermometer is a medical device that received FDA 510(k) clearance on 2016-08-01. It is manufactured by Hangzhou Hua'An Medical&Health Instruments Co.,Ltd. The 510(k) number is K160999.
When was Infra-red forehead thermometer approved by the FDA?
Infra-red forehead thermometer received FDA 510(k) clearance on 2016-08-01, under approval number K160999.
What company makes Infra-red forehead thermometer?
Infra-red forehead thermometer is manufactured by Hangzhou Hua'An Medical&Health Instruments Co.,Ltd.
What is the FDA product code for Infra-red forehead thermometer?
The FDA product code for Infra-red forehead thermometer is FLL.
Other Devices by Hangzhou Hua'An Medical&Health Instruments 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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.