510(k) K180047
- Device
- ESOTEST MULTI Esophageal Temperature Probe And Temperature Monitoring System
- Applicant
- Fiab SpA
- 510(k) number
- K180047
- Product code
- FLL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-11-08
- Date received
- 2018-01-08
- 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
- Alberto Calabro
- Address
- Via Costoli, 4 Vicchio IT 50039 50039
FDA Registration Numbers#
- 3013557562
- 3042579404
- 3013545943
- 1060680
- 3011862780
- 3010106598
- 3008716327
- 3016719957
- 3007048291
- 3016088707
- 2031508
- 3008729547
- 9611500
- 3011200334
- 3008820594
- 2221819
- 3015422337
- 3016674095
- 3032109
- 3006610790
- 3043513123
- 3010476117
- 3017896172
- 3010262192
- 8043323
- 3009191551
- 1836518
- 3009327812
- 3010536822
- 1420054
- 3008879776
- 3006733253
- 1423537
- 3003993690
- 3005841768
- 3027135885
- 3023272766
- 8022257
- 3006636961
- 3005798905
- 3012840029
- 3014271659
- 1055236
- 3003622639
- 3008064428
- 3038610665
- 1220908
- 3019470217
- 3005951243
- 3034993050
- 3008246752
- 3044754336
- 3001084743
- 3008318433
- 3005783425
- 3006142663
- 9617604
- 3018008670
- 3001124136
- 9610105
- 3007413079
- 3026585241
- 9617543
- 1054241
- 3009889471
- 3006169981
- 3013517171
- 3012104670
- 3044174020
- 3004835896
- 3014449259
- 3008687634
- 3004832480
- 3016640651
- 3013019728
- 3023031046
- 3005699784
- 3007154442
- 3011077581
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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