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FDA 510(k)

Non-contact Infrared Thermometer

K-Number: K180207 · 2018-11-28

ApplicantAlicn Medical (Shenzhen), Inc.
Decision Date2018-11-28
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Non-contact Infrared Thermometer is a medical device manufactured by Alicn Medical (Shenzhen), Inc.. It received FDA 510(k) clearance on 2018-11-28 under approval number K180207. 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 Non-contact Infrared Thermometer?

Non-contact Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2018-11-28. It is manufactured by Alicn Medical (Shenzhen), Inc.. The 510(k) number is K180207.

When was Non-contact Infrared Thermometer approved by the FDA?

Non-contact Infrared Thermometer received FDA 510(k) clearance on 2018-11-28, under approval number K180207.

What company makes Non-contact Infrared Thermometer?

Non-contact Infrared Thermometer is manufactured by Alicn Medical (Shenzhen), Inc..

What is the FDA product code for Non-contact Infrared Thermometer?

The FDA product code for Non-contact Infrared Thermometer is FLL.

Related Clinical Trials

NCT07231653 Home Monitoring Study for Surgical Patients NOT_YET_RECRUITING

Other Devices by Alicn Medical (Shenzhen), Inc.

K180435Arm 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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