FDA.report

510(k) K240077

Device
Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)
Applicant
Covidien
510(k) number
K240077
Product code
FLL
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-20
Date received
2024-01-10
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
Angelica Medina
Address
6135 Gunbarrel Ave. Boulder CO US 80301 80301

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
K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd.2025-06-20
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
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