510(k) K232338
- Device
- Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383
- Applicant
- Alicn Medical Shenzhen, Inc.
- 510(k) number
- K232338
- Product code
- FLL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-22
- Date received
- 2023-08-04
- Regulation
- 880.2910
- Classification name
- Continuous Measurement Thermometer
- 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
- Fang Meisong
- Address
- Rm. 410,Bldg. A,3rd Sub-Park, Leibozhongcheng Life Science Park,Kengzi St. Shenzhen CN 518118 518118
FDA Registration Numbers#
- 3004009431
- 3027510187
- 3015142815
- 3028019184
- 3015876
- 9681384
- 3013679558
- 3012804266
- 3013783488
- 3015276780
- 2086043
- 9617543
- 1054421
- 3033530347
- 3007499349
- 3005785090
- 3001570235
- 1216677
- 1034116
- 3014848734
- 3009685433
- 3009673645
- 3036108847
- 3005699784
- 1217805
- 3005536872
- 3044174020
- 3035111606
- 3013481815
- 3006845683
- 3003399181
- 1422443
- 1222304
- 3012316249
- 3002736372
- 3011654863
- 3004215929
- 2320762
- 3010521050
- 9616787
- 3010419931
- 3015140207
- 3009191551
- 3011898560
- 3026585241
- 3015542362
- 3009327812
- 3010106598
- 3016901080
- 3042579404
- 3019470217
- 9611500
- 3011065399
- 3011167030
- 3043479346
- 3014167550
- 3037007069
- 3016866092
- 3000163458
- 1055808
- 3017896172
- 3014271659
- 3008879776
- 3007603826
- 3011835632
- 2111760
- 3006845687
- 1066427
- 3008048783
- 1220908
- 3003965134
- 3005798905
- 3000206696
- 3017619536
- 3010041511
- 3005569927
- 3006082230
- 3027135885
- 3012416077
- 3011137372
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FLL#
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|---|---|---|---|
| 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 |
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| 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 |