510(k) K201582

Device: Non-contact Electronic Forehead Infrared Thermometer
Applicant: Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.
510(k) number: K201582
Product code: FLL
Decision: Substantially Equivalent (SESE)
Decision date: 2021-01-15
Date received: 2020-06-11
Regulation: 880.2910
Classification name: Thermometer, Electronic, Clinical
Medical specialty: General Hospital
Review panel: General Hospital
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Related Records

Applicant Contact

Contact: Jerry Liang
Address: 283rd S. MinAn Rd., Xiaolan Town, Zhongshan City Zhongshan CN 528416 528416

FDA Registration Numbers

3003993690
1423537
9617601
3028019184
3010984687
3003898360
9710548
3006636961
3022028624
3003674698
3033530347
3034993050
3031841433
3007499349
3038613041
1066270
3010288146
2184009
3026753375
3015997711
3010047454
3008246752
9681377
3005841768
1054241
3013019728
3008687634
1928237
3010097171
3017887928
1055808
3013596024
3004026659
3013500228
9610816
3013053058
3015134004
3015697152
3032109
3009673645
3015109923
3009437315
3003903031
3021635975
3014271659
9615140
9617543
3008483389
3006852457
3008167616
3004832480
3009617411
3013826848
3008756507
3007616088
3012309743
3013426279
3008164770
1450057
3037341611
3007413079
8010482
3016719957
3010838917
1422443
2111760
3016904853
3018008670
2320762
3004415095
3038610665
3005798905
3008559238
3014263632
1651104
3008830133
3003971136
3012104670
3021559257

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DI	Brand	Company	Published
06973337423016	KINLee Non-contact Electronic Forehead Infrared Thermomter	Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.	2021-02-02

Other 510(k) Records For Product Code FLL

510(k)	Device	Applicant	Decision date
K251160	Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)	Shenzhen Med-Link Electronics Tech Co., Ltd.	2026-01-08
K250470	Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)	Shenzhen AOJ Medical Technology Co., Ltd.	2025-06-23
K243000	Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)	Shenzhen Medke Technology Co., Ltd.	2025-06-20
K250878	YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)	Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.	2025-05-22
K243082	Infrared Thermometer	Guangzhou Daxin Health Technology Co., Ltd.	2025-04-25
K250401	AION TempShield	Aion Biosystems, Inc.	2025-03-14
K243136	Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)	Shenzhen Finicare Co., Ltd.	2025-02-14
K240333	Wearable Digital Thermometer (T31)	Guangdong Genial Technology Co., Ltd.	2024-10-30
K240223	FMT Disposable and Autoclavable Temperature Probes	Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi	2024-10-25
K240220	Aulisa Temperature Module (TM0002)	Taiwan Aulisa Medical Devices Technologies, Inc.	2024-09-27
K240077	Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044)	Covidien	2024-08-20
K233280	SteadyTemp	Steadysense GmbH	2024-06-21
K240648	Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)	Radiant Innovation, Inc.	2024-06-05
K240109	Medical electronic thermometer (FC01, FC02)	Zhuzhou Goldenhot Medical Technology Co., Ltd.	2024-04-12
K233192	Wireless Smart Thermometer	Famidoc Technology Company Limited	2024-04-05

Legacy Summary

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