FDA.report

510(k) K232473

Device
Infrared Thermometer: Model YJ600
Applicant
Zhuhai Yueja Medical Device Technology Co., Ltd.
510(k) number
K232473
Product code
FLL
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-09
Date received
2023-08-16
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
Feng Yan
Address
Rm. 201, Bldg. 2, #2 Liushi Rd., Tangjiawan Town, High-Tech Zone Zhuhai CN 519000 519000

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

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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