510(k) K201032
- Device
- Phoenix Digital Thermometer
- Applicant
- Phoenix Innovative Healthcare Manufacturers Pvt. Ltd.
- 510(k) number
- K201032
- Product code
- FLL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-10-29
- Date received
- 2020-04-20
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ramshankar Ghosh
- Address
- El-209 Shil Mahape Rd. Electronic Zone Midc, Ttc Industrial Area Mahape, Navi Mumbai IN 400710 400710
FDA Registration Numbers#
- 3014468707
- 3037007069
- 3007748817
- 3005951403
- 3018783553
- 3034603279
- 3013826848
- 3038761440
- 3003622639
- 3006082230
- 3009437315
- 9616085
- 3016867013
- 3044854644
- 3007413079
- 2648045
- 8030673
- 3007307487
- 9615140
- 3008770708
- 9617604
- 1123010
- 3007154442
- 3009831876
- 2221819
- 3003965134
- 3003174284
- 3042156936
- 3007502227
- 3010476117
- 3003832357
- 3011353843
- 3036108847
- 3013545943
- 9613304
- 3005583357
- 9616843
- 1651104
- 3005536872
- 3044174020
- 3008164770
- 1832894
- 3017896172
- 8010026
- 3022028624
- 1250045
- 3004415095
- 3008729547
- 3017619536
- 3027510187
- 3000268902
- 3008879776
- 3010968402
- 3014886121
- 3003399181
- 3013689228
- 2032273
- 3016075711
- 3015188281
- 3000206696
- 3008361498
- 3007305624
- 3012312061
- 3028107593
- 3014774380
- 3024790242
- 3006733253
- 3010370454
- 3023412068
- 3010262192
- 3000163458
- 3003697998
- 3007731000
- 3011243696
- 3012421607
- 2133786
- 1423537
- 3008808082
- 3006648320
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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FDA Review#
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