FDA.report

510(k) K213100

Device
FMT Reusable Temperature Probes
Applicant
Metko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti
510(k) number
K213100
Product code
FLL
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-18
Date received
2021-09-24
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
Statement
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Burcu Firat
Address
Ivedik O.S.B. Agac Isleri Sanayi Sitesi 1354, Cad. 1358. Sok No:9 Yenimahalle - Ankara TR 06378 06378

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · 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
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