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)

Non-contact Forehead Thermometer

K-Number: K161735 · 2016-11-17

ApplicantShenzhen Dongdixin Technology Co., Ltd.
Decision Date2016-11-17
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Non-contact Forehead Thermometer is a medical device manufactured by Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-11-17 under approval number K161735. 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 Forehead Thermometer?

Non-contact Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2016-11-17. It is manufactured by Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K161735.

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

Non-contact Forehead Thermometer received FDA 510(k) clearance on 2016-11-17, under approval number K161735.

What company makes Non-contact Forehead Thermometer?

Non-contact Forehead Thermometer is manufactured by Shenzhen Dongdixin Technology Co., Ltd..

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

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

Related Clinical Trials

NCT07231653 Home Monitoring Study for Surgical Patients NOT_YET_RECRUITING NCT06718764 Neurosteer Bedside Monitoring System RECRUITING

Other Devices by Shenzhen Dongdixin Technology Co., Ltd.

K173462Wireless Pain Relieve Device Model: LT5018C K171978Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 K162479Smart Pain Reliever, Model LT5019 K180331Wireless Pain Relieve Device K171430Incontinence Treatment Device, Model LT2061 K210364Migraine Tens Digital Pain Reliever

View all 9 devices →

Related Devices (Code: FLL)

K160306Cloud Smart ThermometerGuangzhou Bosma Technology Co, Ltd. K161728Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1Microfile Intellectual Property GmbH 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. K161933The Braun ThermoScan® 3 High Speed Compact Ear ThermometerKaz USA, Inc., A Helen of Troy Company

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.

↑