510(k) K092958
- Device
- AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES
- Applicant
- AVITA CORPORATION
- 510(k) number
- K092958
- Product code
- FLL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-12-02
- Date received
- 2009-09-25
- Regulation
- 880.2910
- Classification name
- Thermometer, Electronic, Clinical
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JENNIFER REICH
- Address
- 2904 N. Boldt Dr. Flagstaff AZ US 86001 86001
FDA Registration Numbers#
- 3008361498
- 3011353843
- 9617601
- 3011654863
- 3032948391
- 3012725363
- 3034405508
- 3013500228
- 9613304
- 8010482
- 2182318
- 3001084743
- 3014848734
- 3005783425
- 3010968402
- 3017493034
- 3014421917
- 1420054
- 3007154442
- 2031508
- 3030671608
- 3010405299
- 3010106598
- 9616787
- 3017406171
- 3008246752
- 3005583357
- 3011137372
- 3013596024
- 3016618143
- 1222304
- 3003399181
- 1055236
- 9710602
- 3003687189
- 3006845687
- 3017422354
- 3030447506
- 3015276780
- 3014235520
- 3005699784
- 3003965134
- 3007770159
- 3010370454
- 3015422337
- 9615817
- 3010047454
- 3013689228
- 3016693518
- 3023412068
- 3012416077
- 3004485927
- 3005621440
- 3009889471
- 3004727197
- 3003072803
- 3014856521
- 3007838093
- 8043323
- 1651104
- 3043513123
- 3006733253
- 1018233
- 1836518
- 1034116
- 1054241
- 1066444
- 2081040
- 3009831876
- 2086043
- 3037341611
- 3004035727
- 3000215556
- 3019470217
- 3010390468
- 2011171
- 3018783553
- 2410808
- 3004215929
- 3026585241
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