QME
- 产品代码
- QME
- 器械名称
- Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 870.2785
- FDA 专业组
- Cardiovascular
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 13 件
FDA 分类定义
The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy.
该代码近三年的 510(k)（9 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K254169 | 2026-06-18 | Presage Security, Inc. d/b/a Presage T | SmartSpectra Vital Signs Monitor 1.0 | |
| K253650 | 2026-06-11 | Nuralogix Corporation | Anura Mobile Core SDK (M1) | |
| K260066 | 2026-05-21 | PanopticAI Technologies Limited | PanopticAI Vital Signs (1.6.1-22) | |
| K251200 | 2026-02-02 | Oxehealth Limited | Vital Signs | |
| K243687 | 2025-08-27 | Oxehealth Limited | Vital Signs | |
| K250078 | 2025-05-30 | Mindset Medical, Inc. | Informed Vital Core Application (IVC App) (v2.0.0.2. | |
| K240890 | 2024-12-23 | PanopticAI technologies Limited | PanopticAI Vital Signs | |
| K241633 | 2024-11-18 | Mindset Medical, Inc. | Informed Vital Core Application (IVC App) | |
| K232804 | 2024-06-07 | Qompium NV | FibriCheck |
FDA 官方分类页： QME
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。