510(k) K180387
- Device
- Infrared Ear Thermometer
- Applicant
- HeTaiDa Technology Co., Ltd.
- 510(k) number
- K180387
- Product code
- FLL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-01-10
- Date received
- 2018-02-12
- 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
- Tom Chen
- Address
- 4f, Baishida High-Tech Park, Xiangdong Industrial Area Dalingshan Town Foshan City CN 523820 523820
FDA Registration Numbers#
- 3008975047
- 3007407626
- 3004215929
- 3004911384
- 3021422553
- 3012302888
- 3032948391
- 2320762
- 3008048783
- 3006169981
- 1066427
- 1250045
- 3013053058
- 3042156936
- 3017896172
- 3005841768
- 3006648320
- 3017520431
- 3013783488
- 3017894657
- 3016719957
- 3011792045
- 3009124884
- 3003674698
- 3026264
- 3003697998
- 3034405508
- 3009756153
- 3012804266
- 3013596024
- 3012416077
- 3009191551
- 3017973191
- 3030626857
- 3007502227
- 3005798905
- 1123010
- 3008771621
- 3008820594
- 3007731000
- 2025816
- 3003993690
- 3008756507
- 3005951403
- 3033536319
- 3007007790
- 3016705853
- 3009685433
- 3006845683
- 3017446092
- 3027605322
- 2221819
- 3028172072
- 3008716327
- 3033530347
- 3007616088
- 3013557562
- 3016850322
- 3015188281
- 3015140207
- 3008729899
- 3010097171
- 3012316249
- 3003589956
- 3043668257
- 3012840029
- 3026585241
- 3032109
- 3008770708
- 9616085
- 3011200334
- 3000163458
- 3014167550
- 3008879776
- 2032112
- 3009973336
- 3015142815
- 2086043
- 9681384
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#
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