Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Infrared Thermometer

K-Number: K222248 · 2023-06-07

ApplicantAlicn Medical Shenzhen, Inc.
Decision Date2023-06-07
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Thermometer is a medical device manufactured by Alicn Medical Shenzhen, Inc.. It received FDA 510(k) clearance on 2023-06-07 under approval number K222248. 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?

Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2023-06-07. It is manufactured by Alicn Medical Shenzhen, Inc.. The 510(k) number is K222248.

When was Infrared Thermometer approved by the FDA?

Infrared Thermometer received FDA 510(k) clearance on 2023-06-07, under approval number K222248.

What company makes Infrared Thermometer?

Infrared Thermometer is manufactured by Alicn Medical Shenzhen, Inc..

What is the FDA product code for Infrared Thermometer?

The FDA product code for Infrared Thermometer is FLL.

Other Devices by Alicn Medical Shenzhen, Inc.

K210563Arm Blood Pressure Monitor K221913Arm Blood Pressure Monitor K210937Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 K210565Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711 K212257Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311 K212877Arm Blood Pressure Monitor

View all 11 devices →

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.

↑