510(k) K031905
- Device
- DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136, AND ACT 3030
- Applicant
- Actherm, Inc.
- 510(k) number
- K031905
- Product code
- FLL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-07-07
- Date received
- 2003-06-20
- Regulation
- 880.2910
- Classification name
- Continuous Measurement Thermometer
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD HSIEH
- Address
- 6th F, No 85 Kuan-Min 6 Rd. Jubei 302 Hsinchu TW 302 302
FDA Registration Numbers#
- 3003993690
- 1423537
- 9617601
- 3028019184
- 3010984687
- 3003898360
- 9710548
- 3006636961
- 3022028624
- 3003674698
- 3033530347
- 3034993050
- 3031841433
- 3007499349
- 3038613041
- 1066270
- 3010288146
- 2184009
- 3026753375
- 3015997711
- 3010047454
- 3008246752
- 9681377
- 3005841768
- 1054241
- 3013019728
- 3008687634
- 1928237
- 3010097171
- 3017887928
- 1055808
- 3013596024
- 3004026659
- 3013500228
- 9610816
- 3013053058
- 3015134004
- 3015697152
- 3032109
- 3009673645
- 3015109923
- 3009437315
- 3003903031
- 3021635975
- 3014271659
- 9615140
- 9617543
- 3008483389
- 3006852457
- 3008167616
- 3004832480
- 3009617411
- 3013826848
- 3008756507
- 3007616088
- 3012309743
- 3013426279
- 3008164770
- 1450057
- 3037341611
- 3007413079
- 8010482
- 3016719957
- 3010838917
- 1422443
- 2111760
- 3016904853
- 3018008670
- 2320762
- 3004415095
- 3038610665
- 3005798905
- 3008559238
- 3014263632
- 1651104
- 3008830133
- 3003971136
- 3012104670
- 3021559257
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FLL#
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|---|---|---|---|
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| 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 |
| K233192 | Wireless Smart Thermometer | Famidoc Technology Company Limited | 2024-04-05 |