510(k) K163518
- Device
- Digital Thermometer
- Applicant
- JOYTECH HEALTHCARE CO., LTD
- 510(k) number
- K163518
- Product code
- FLL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-09-19
- Date received
- 2016-12-15
- 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
- Ren Yunhua
- Address
- # 365. Wuzhou Rd., Yuhang Economic Development Zone Hangzhou CN 311100 311100
FDA Registration Numbers#
- 3009831876
- 3010852191
- 3023272766
- 1055808
- 3005798905
- 3003832357
- 2518422
- 2082313
- 1718850
- 3026585241
- 3026264
- 3011167030
- 3032948391
- 3015142935
- 1422443
- 3016452327
- 3008246752
- 2133641
- 3009617411
- 1018233
- 1060680
- 3009889471
- 3007407626
- 3003993690
- 3004026659
- 3017643152
- 1723241
- 3014541700
- 3043668257
- 3005785090
- 3006537699
- 3010317211
- 3008559238
- 9710641
- 3004111573
- 3016674095
- 3001084743
- 3012316249
- 3012295567
- 3008307705
- 2434115
- 3000206696
- 3009327812
- 3004009431
- 3013823570
- 3016640651
- 3015997711
- 3037007069
- 3003630387
- 3010476117
- 3005583357
- 3010157426
- 3019388613
- 3007703436
- 3006845687
- 3007731000
- 3011792045
- 3013783488
- 3007748817
- 3030671608
- 3003399181
- 3011077581
- 3004215929
- 1221195
- 3009001657
- 3004035727
- 3015876
- 9710602
- 3006176286
- 1043214
- 3008167616
- 3000163458
- 3005951243
- 3033530347
- 1314417
- 3007134734
- 3023412068
- 9615817
- 3008841035
- 3003657019
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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