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FDA 510(k)

Infrared Ear Thermometer

K-Number: K153146 · 2016-03-31

ApplicantSejoy Electronics & Instruments Co., Ltd.
Decision Date2016-03-31
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Ear Thermometer is a medical device manufactured by Sejoy Electronics & Instruments Co., Ltd.. It received FDA 510(k) clearance on 2016-03-31 under approval number K153146. 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 Ear Thermometer?

Infrared Ear Thermometer is a medical device that received FDA 510(k) clearance on 2016-03-31. It is manufactured by Sejoy Electronics & Instruments Co., Ltd.. The 510(k) number is K153146.

When was Infrared Ear Thermometer approved by the FDA?

Infrared Ear Thermometer received FDA 510(k) clearance on 2016-03-31, under approval number K153146.

What company makes Infrared Ear Thermometer?

Infrared Ear Thermometer is manufactured by Sejoy Electronics & Instruments Co., Ltd..

What is the FDA product code for Infrared Ear Thermometer?

The FDA product code for Infrared Ear Thermometer is FLL.

Other Devices by Sejoy Electronics & Instruments Co., Ltd.

K153149Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36 K161577Arm-Type Fully Automatic Digital Blood Pressure Monitor

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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