510(k) K851147
- Device
- AUTORANGING DIGITAL CLINICAL THERMOMETER
- Applicant
- MICRO IDEA INSTRUMENT CO., LTD.
- 510(k) number
- K851147
- Product code
- FLL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-05-23
- Date received
- 1985-03-21
- Regulation
- 880.2910
- Classification name
- Thermometer, Electronic, Clinical
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LIN
- Address
- R.501, No 147, Sec. 2 Chien Duo North Road Taipei, Taiwan TW
FDA Registration Numbers#
- 3007731000
- 3031841433
- 3027135885
- 3049808762
- 3042156936
- 3043479346
- 1836518
- 2011171
- 3005841768
- 3014856521
- 3017643152
- 3008956776
- 3006845687
- 3020848330
- 9616843
- 3005536872
- 3006792041
- 1018233
- 3000215556
- 3007838093
- 3008048783
- 3017896172
- 3041276591
- 2437780
- 2081040
- 1417592
- 3003622639
- 3004111573
- 2082313
- 9613793
- 3006648320
- 3016693518
- 3003697998
- 3009156722
- 1120986
- 3013896610
- 3012494290
- 3018783526
- 3021559257
- 3004871905
- 3013500228
- 3008384335
- 3007502227
- 3015134004
- 3008164770
- 3016867013
- 2111760
- 3006610790
- 3005877899
- 3007305624
- 3013826848
- 3015188281
- 3003674698
- 3010822231
- 3034405508
- 3012678246
- 3010984687
- 2032273
- 3007307487
- 2381321
- 3030597679
- 1221195
- 3016901080
- 3011182134
- 3013426279
- 3016864576
- 3002736372
- 1066427
- 3009327812
- 3019470217
- 3034993050
- 3027605322
- 3003887292
- 3026753375
- 3012302888
- 3033530347
- 3042579404
- 1055808
- 2032112
- 3043513123
Source Documents#
510(k) summary PDF not indicated by FDA
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