FDA.report

510(k) K243000

Device
Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)
Applicant
Shenzhen Medke Technology Co., Ltd.
510(k) number
K243000
Product code
FLL
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-20
Date received
2024-09-26
Regulation
880.2910
Classification name
Continuous Measurement Thermometer
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Wei Tao Li
Address
4/F, Bldg. A1, Anle Ind. Zone, Hangcheng Rd., Baoan District Shenzhen CN 518126 518126

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code FLL

510(k)DeviceApplicantDecision date
K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd.2026-01-08
K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd.2025-06-23
K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2025-05-22
K243082Infrared ThermometerGuangzhou Daxin Health Technology Co., Ltd.2025-04-25
K250401AION TempShield™Aion Biosystems, Inc.2025-03-14
K243136Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)Shenzhen Finicare Co., Ltd.2025-02-14
K240333Wearable Digital Thermometer (T31)Guangdong Genial Technology Co., Ltd.2024-10-30
K240223FMT Disposable and Autoclavable Temperature ProbesMetko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi2024-10-25
K240220Aulisa Temperature Module (TM0002)Taiwan Aulisa Medical Devices Technologies, Inc.2024-09-27
K240077Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)Covidien2024-08-20
K233280SteadyTempSteadysense GmbH2024-06-21
K240648Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)Radiant Innovation, Inc.2024-06-05
K240109Medical electronic thermometer (FC01, FC02)Zhuzhou Goldenhot Medical Technology Co., Ltd.2024-04-12
K233192Wireless Smart ThermometerFamidoc Technology Company Limited2024-04-05
K230889Digital ThermometerWenzhou Yosun Medical Technology Co.,Ltd2024-04-03