510(k) K182133
- Device
- Infrared Thermometer
- Applicant
- Shenzhen AOJ Medical Technology Co., Ltd.
- 510(k) number
- K182133
- Product code
- FLL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-11-20
- Date received
- 2018-08-06
- 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
Applicant Contact#
- Contact
- Qihuan Zhao
- Address
- Rm. 202, Haogu Industry Park, 2037 Guanguang Rd., Guangming District Shenzhen CN 518103 518103
FDA Registration Numbers#
- 3010262192
- 3008559238
- 3027344406
- 3008830133
- 9613558
- 3009001657
- 3010838917
- 3010390468
- 1921846
- 3004009431
- 3009124884
- 3004101980
- 3001650535
- 2381321
- 1423537
- 3000268902
- 3015140207
- 1832894
- 3004112621
- 3011654863
- 3006537699
- 3021635975
- 9615140
- 3003072803
- 3016864576
- 1314417
- 8043685
- 3005798905
- 9616085
- 3006140792
- 9616843
- 3003263092
- 3042272797
- 3027285900
- 3005031124
- 3030626857
- 9610816
- 3021186226
- 3033530347
- 3004832480
- 3011862780
- 3004111573
- 1720734
- 9710602
- 3008064428
- 3030597679
- 3031841433
- 3005699784
- 3013053058
- 1066444
- 3003591740
- 3034405508
- 3009328501
- 3007748817
- 3003687189
- 2936999
- 3007307487
- 3011191255
- 2410808
- 8020605
- 3016693518
- 3009518322
- 3027135885
- 3026264
- 3013426279
- 3024512705
- 3037724692
- 3038761440
- 3007616088
- 3037341611
- 3015109923
- 3012494290
- 3008975047
- 3017825461
- 9617604
- 3008879776
- 3008808082
- 3017894657
- 2030624
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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