MNR
- 产品代码
- MNR
- 器械名称
- Ventilatory Effort Recorder
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 868.2375
- FDA 专业组
- Anesthesiology
- 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)
- 164 件
该代码近三年的 510(k)（21 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K254042 | 2026-07-31 | Itamar Medical , Ltd. | WatchPAT SW | |
| K260050 | 2026-07-15 | Huneo, LLC | WRAP System | |
| K253148 | 2026-06-22 | Vivaquant, Inc. Dba Rhythm Express | RX-1 Sleep | |
| K252628 | 2026-04-27 | Wesper, Inc. | CASSIE | |
| K252497 | 2025-12-10 | Huxley Medical | SANSA HSAT | |
| K250882 | 2025-10-29 | Huxley Medical | SANSA HSAT | |
| K250460 | 2025-09-05 | Itamar Medical , Ltd. | WatchPAT400 (WP400) | |
| K252383 | 2025-08-28 | Compumedics Limited | Somfit D | |
| K243220 | 2025-07-03 | Onera B.V. | Onera STS 2 (ONERA STS 2) | |
| K242224 | 2025-06-18 | Happy Health, Inc. | Happy Health Home Sleep Test | |
| K243092 | 2025-03-19 | Acurable Limited | AcuPebble Ox (200) | |
| K243268 | 2025-02-03 | Pranaq Pte. , Ltd. | TipTraQ (TTQ001) | |
| K244027 | 2025-01-28 | Huxley Medical | SANSA HSAT | |
| K242290 | 2025-01-08 | Dormotech Medical, Ltd. | DormoTech NLab | |
| K242424 | 2024-12-18 | Cadwell Industries, Inc. | Bluebird Single-Use Respiratory Effort Belt | |
| K231667 | 2024-09-06 | Withings | Withings Sleep Rx | |
| K233501 | 2024-07-26 | Largan Medical Co., Ltd. | LARGAN Health AI-Tech Sleep Apnea and Sleep Qualit | FDA |
| K240285 | 2024-07-15 | Huxley Medical | Huxley SANSA Home Sleep Apnea Test (1000-00) | |
| K240100 | 2024-06-04 | Snap Diagnostics, LLC | SAM Model 9-10000 | |
| K231355 | 2024-02-09 | Ensodata | Aurora | |
| K231546 | 2023-11-30 | Compumedics Limited | Somfit |
FDA 官方分类页： MNR
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。