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 (Model K9)

K-Number: K203497 · 2021-10-08

ApplicantKangzhan Communication Electronics Co., Ltd.
Decision Date2021-10-08
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Thermometer (Model K9) is a medical device manufactured by Kangzhan Communication Electronics Co., Ltd.. It received FDA 510(k) clearance on 2021-10-08 under approval number K203497. 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 (Model K9)?

Infrared Thermometer (Model K9) is a medical device that received FDA 510(k) clearance on 2021-10-08. It is manufactured by Kangzhan Communication Electronics Co., Ltd.. The 510(k) number is K203497.

When was Infrared Thermometer (Model K9) approved by the FDA?

Infrared Thermometer (Model K9) received FDA 510(k) clearance on 2021-10-08, under approval number K203497.

What company makes Infrared Thermometer (Model K9)?

Infrared Thermometer (Model K9) is manufactured by Kangzhan Communication Electronics Co., Ltd..

What is the FDA product code for Infrared Thermometer (Model K9)?

The FDA product code for Infrared Thermometer (Model K9) is FLL.

Related Clinical Trials

NCT07034521 The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors RECRUITING

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.

↑