510(k) K050837
- Device
- REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE
- Applicant
- GE HEALTHCARE
- 510(k) number
- K050837
- Product code
- FLL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-04-27
- Date received
- 2005-04-01
- 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
- JOEL KENT
- Address
- 86 Pilgrim Rd. Needham MA US 02492 02492
FDA Registration Numbers#
- 3010106598
- 3044174020
- 3011835632
- 3016640651
- 3017887928
- 3013298431
- 9710548
- 3012312061
- 3000163458
- 3001084743
- 3012309743
- 3033715634
- 1000137876
- 3005798905
- 3042579404
- 3005785090
- 3011191255
- 3004145393
- 3007137643
- 1220908
- 3012416077
- 3014271659
- 3006157842
- 3018783526
- 3013053058
- 9615817
- 3008756507
- 3009518322
- 3035111606
- 3028172072
- 3004101980
- 3009889471
- 3021343210
- 9617604
- 8010482
- 3017858797
- 3008879776
- 3009685433
- 2184009
- 2221819
- 9681384
- 3008361498
- 3012528160
- 3016867013
- 2133641
- 3003687189
- 3016509757
- 9710641
- 1062836
- 8030673
- 3012104670
- 3007838093
- 3037341611
- 3006636961
- 3014015501
- 3005536872
- 1718850
- 3008058135
- 3014848734
- 9613304
- 3012359877
- 3021559257
- 3014541700
- 2025816
- 3005783425
- 3014774380
- 3001570235
- 3005951403
- 3016618143
- 3013481815
- 3026585241
- 3006648320
- 3003660459
- 2183924
- 3017894657
- 1928237
- 3009499478
- 3018094310
- 3010288146
- 3012834717
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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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