510(k) K070878
- Device
- DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300
- Applicant
- RG MEDICAL DIAGNOSTICS
- 510(k) number
- K070878
- Product code
- FLL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-06-05
- Date received
- 2007-03-29
- 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
- RONALD G LE TOURNEAU
- Address
- 21130 Bridge St. Southfield MI US 48034 48034
FDA Registration Numbers#
- 3044174020
- 3007731000
- 1450057
- 2133786
- 3016850322
- 3003887292
- 3015967131
- 3003981912
- 3006610790
- 3010521050
- 3006845683
- 3011137372
- 1721686
- 3038259592
- 3011182134
- 3049808762
- 3032109181
- 1718850
- 3010262192
- 3009756153
- 3012840029
- 8022257
- 3012528160
- 3017446092
- 3010157426
- 3036108847
- 3043226252
- 8020605
- 3024999438
- 3011713222
- 9615817
- 3027605322
- 3005783425
- 3007307487
- 3017406171
- 3017520431
- 2320762
- 3017858797
- 1723241
- 3004112621
- 3009499478
- 3008318433
- 3001570235
- 3009551875
- 3023031046
- 3042156936
- 3024491912
- 3031841433
- 3009888765
- 3006537699
- 1835242
- 1062836
- 3026032283
- 1218950
- 3009156722
- 3027285900
- 3003965134
- 3004871905
- 3024790242
- 3007499349
- 9681384
- 1423537
- 3006636961
- 3010047454
- 3004026659
- 3004111573
- 3018008670
- 1055236
- 3014449259
- 3030447506
- 2011171
- 3012494290
- 3011654863
- 3006852457
- 3019737388
- 3008756507
- 1417592
- 3013596024
- 3016595211
- 8043685
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#
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