FDA.report

510(k) K232128

Device
Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)
Applicant
Shenzhen AOJ Medical Technology Co., Ltd.
510(k) number
K232128
Product code
FLL
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-14
Date received
2023-07-17
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
Jack Wang
Address
Rm. 301&4f, Blk A, Bldg. A, Jingfa Im Park Xiaweiyuan, Gushu Community, Xixiang, 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
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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