510(k) K101387
- Device
- DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN
- Applicant
- FUDAKANG INDUSTRIES CO., LTD
- 510(k) number
- K101387
- Product code
- FLL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-08-03
- Date received
- 2010-05-18
- 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
- Yes
Applicant Contact#
- Contact
- STEPHEN LING
- Address
- Rm.2706 Block A, Zhongfang Jinyuan Bldg, Xinwen Rd. Shenzhen, Guangdong CN 518034 518034
FDA Registration Numbers#
- 3032109181
- 3008384335
- 3018783553
- 3012316249
- 3013496867
- 3008307705
- 3027135885
- 9617543
- 3003903031
- 3014886121
- 3014015501
- 1000122786
- 3004835896
- 3001124136
- 3013053058
- 3011167030
- 3016670149
- 3043226252
- 3003591740
- 3001650535
- 3008064428
- 9681384
- 2434008
- 9680961
- 2182318
- 3027285900
- 1036863
- 3004111573
- 9710548
- 3007413079
- 3013019728
- 3016674095
- 3016075711
- 3014449259
- 3029824200
- 3013896610
- 9680225
- 3032109
- 3008167616
- 3005621440
- 3014167550
- 3005877899
- 2030624
- 3006979678
- 3009456923
- 1316463
- 3009077524
- 1718850
- 3010047454
- 3026032283
- 3013557562
- 3014235520
- 3038295706
- 3038610665
- 1450057
- 3015422337
- 3003832357
- 3001570235
- 3042156936
- 3003263092
- 3038280948
- 1650347
- 1928237
- 3005905524
- 3042272797
- 3003660459
- 3023272766
- 3014856521
- 3004035727
- 3016901080
- 9611500
- 3030597679
- 3003174284
- 3015967131
- 3010822231
- 1018233
- 3005798905
- 3015876
- 3010370454
Source Documents#
Other 510(k) Records For Product Code FLL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253162 | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG) | Unimed Medical Supplies, Inc. | 2026-06-05 |
| 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 |
Legacy Summary#
summary
FDA Review#
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