510(k) K203656
- Device
- Non-Contact Forehead Thermometer (UT30H)
- Applicant
- Uni-Trend Technology(CHINA) CO.,LTD
- 510(k) number
- K203656
- Product code
- FLL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-01-22
- Date received
- 2020-12-15
- 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
- Mike Mao
- Address
- No 6, Gong Ye Bei 1st Rd., Songshan Lake National High-Tech Industrial Development Dongguan CN
FDA Registration Numbers#
- 9611500
- 9617601
- 9615817
- 3008754120
- 3008246752
- 3010047454
- 3009685433
- 3021635975
- 3027510187
- 9616085
- 3010419931
- 8043323
- 1450057
- 2111760
- 1054421
- 3012359877
- 3032916632
- 3005536872
- 3008167616
- 1720839
- 3000163458
- 3017894657
- 3001650535
- 3030597679
- 8043685
- 3008058135
- 3007748817
- 3017520431
- 3009518322
- 2936999
- 3015134004
- 3012678246
- 2132111
- 3018783553
- 3038295706
- 9613793
- 3012312061
- 3018188848
- 9681834
- 3012416077
- 3016850322
- 3018094310
- 1043214
- 3019470217
- 1419898
- 3008507279
- 3032109
- 3008756507
- 3008011951
- 3008808082
- 3018514222
- 3009889471
- 3013019728
- 2133641
- 3010157426
- 3010370454
- 3005841768
- 3009437315
- 3006636961
- 3003981912
- 3008733163
- 3015276780
- 3015455735
- 3008975047
- 3004111573
- 3008771621
- 3008164770
- 3004215929
- 3023031046
- 3015142935
- 3004145393
- 3011077581
- 3003993690
- 3001084743
- 2183924
- 3037007069
- 1836518
- 1651104
- 8020605
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#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases