FLL
- 产品代码
- FLL
- 器械名称
- Continuous Measurement Thermometer
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 880.2910
- FDA 专业组
- General Hospital
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 798 件
FDA 分类定义
A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.
该代码近三年的 510(k)（24 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K253162 | 2026-06-05 | Unimed Medical Supplies, Inc. | Temperature probes (T2252-PG); Temperature probes (T 摘要 |
| K251160 | 2026-01-08 | Shenzhen Med-Link Electronics Tech Co. | Sterile temperature probe (Model: W0001ES, W0028ES, 摘要 |
| K250470 | 2025-06-23 | Shenzhen AOJ Medical Technology Co., L | Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E10 摘要 |
| K243000 | 2025-06-20 | Shenzhen Medke Technology Co., Ltd. | Reusable Temperature Probe (T1306, T2306, T3306, T43 摘要 |
| K250878 | 2025-05-22 | Jiangsu Yuyue Medical Equipment & Supp | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® I 摘要 |
| K243082 | 2025-04-25 | Guangzhou Daxin Health Technology Co., | Infrared Thermometer 摘要 |
| K250401 | 2025-03-14 | Aion Biosystems, Inc. | AION TempShield 摘要 |
| K243136 | 2025-02-14 | Shenzhen Finicare Co., Ltd. | Non-contact Forehead Infrared Thermometer (FC-IR2000 摘要 |
| K240333 | 2024-10-30 | Guangdong Genial Technology Co., Ltd. | Wearable Digital Thermometer (T31) 摘要 |
| K240223 | 2024-10-25 | Metko Medikal VE Tibbi Cihazlar Dis Ti | FMT Disposable and Autoclavable Temperature Probes |
| K240220 | 2024-09-27 | Taiwan Aulisa Medical Devices Technolo | Aulisa Temperature Module (TM0002) 摘要 |
| K240077 | 2024-08-20 | Covidien | Mon-a-Therm General Purpose Temperature Probe 400TM 摘要 |
| K233280 | 2024-06-21 | Steadysense GmbH | SteadyTemp 摘要 |
| K240648 | 2024-06-05 | Radiant Innovation, Inc. | Non-contact Forehead Thermomete (TH48FE, TH09F, THD2 摘要 |
| K240109 | 2024-04-12 | Zhuzhou Goldenhot Medical Technology C | Medical electronic thermometer (FC01, FC02) 摘要 |
| K233192 | 2024-04-05 | Famidoc Technology Company Limited | Wireless Smart Thermometer 摘要 |
| K230889 | 2024-04-03 | Wenzhou Yosun Medical Technology Co.,L | Digital Thermometer |
| K240023 | 2024-03-01 | Shenzhen YI Fang Blister Packaging Co. | Probe Covers (YF-001, YF-002) 摘要 |
| K232473 | 2024-02-09 | Zhuhai Yueja Medical Device Technology | Infrared Thermometer: Model YJ600 摘要 |
| K231625 | 2024-02-02 | Wellvii, Inc. | VitalDetect 摘要 |
| K232678 | 2024-01-31 | Guangdong Genial Technology Co., Ltd. | Digital Thermometer, Model T28, T28L |
| K232338 | 2023-12-22 | Alicn Medical Shenzhen, Inc. | Electronic Thermometer, Model: AET-F331, AET-F332, A |
| K222057 | 2023-12-05 | T&R BIOFAB CO., Ltd. | THERMOCLICK 摘要 |
| K232128 | 2023-10-14 | Shenzhen AOJ Medical Technology Co., L | Infrared Thermometer (AOJ-20A); Infrared Thermometer 摘要 |
FDA 官方分类页： FLL
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。