BZD
- 产品代码
- BZD
- 器械名称
- Ventilator, Non-Continuous (Respirator)
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 868.5905
- FDA 专业组
- Anesthesiology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 461 件
该代码近三年的 510(k)（26 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K253044 | 2026-07-23 | Resvent Medical Technology Co., Ltd. | RXiBreeze PAP System (RXiBreeze 20C) 摘要 |
| K253553 | 2026-06-04 | Resmed Corp | Orion 摘要 |
| K254104 | 2026-05-27 | Resmed Corp | ResScan Essentials 摘要 |
| K251920 | 2026-05-21 | Dcstar, Inc. | Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full 摘要 |
| K253166 | 2026-04-29 | BMC Medical Co., Ltd. | F6S Full Face Mask (F6S); P6S Nasal Pillows Interfac 摘要 |
| K252338 | 2026-04-17 | Somnetics International, Inc. (Dba Tra | MySleepDash 摘要 |
| K251847 | 2026-01-15 | Sleepnet Corporation | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie N 摘要 |
| K253939 | 2026-01-07 | RemSleep Holdings, Inc. | DeltaWave Nasal Pillow System 摘要 |
| K251770 | 2025-12-15 | Sleepres, Inc. | SleepRes PAP System 摘要 |
| K251657 | 2025-12-05 | Resmed Corp | Personalized Therapy Comfort Settings (PTCS) 摘要 |
| K243583 | 2025-06-18 | Fisher & Paykel Healthcare Limited | F&P Nova Nasal Mask 摘要 |
| K250624 | 2025-05-28 | Resmed Corp | myAir 摘要 |
| K243023 | 2025-05-23 | Wellell, Inc. | WiZARD 520 Full Face Mask 摘要 |
| K242547 | 2025-05-19 | Resmed Pty , Ltd. | AirFit F20 Mask System; AirFit F20 NM Mask System 摘要 |
| K242935 | 2025-01-15 | BMC Medical Co., Ltd. | Respiration Data Management Software (PAP Link PC) 摘要 |
| K243225 | 2024-12-31 | Genadyne Biotechnologies, Inc. | Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal 摘要 |
| K241830 | 2024-10-18 | Sleepnet Corporation | Mojo Full Face Vented Mask; Veraseal 2 Full Face Ven 摘要 |
| K241939 | 2024-09-27 | Resmed Corp | EasyCare Tx 2 摘要 |
| K241216 | 2024-09-26 | Resmed Corp | myAir 摘要 |
| K234134 | 2024-09-24 | Resmed Pty Ltd (Registration Number: 3 | AirFit F30i Mask System; AirFit F30i NM Mask System; 摘要 |
| K233829 | 2024-08-23 | Fisher and Paykel Healthcare Limited | Nova Micro Pillows Mask Small A Model (NVP1SA); Nova 摘要 |
| K233555 | 2024-07-31 | Philips Respironics | AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal 摘要 |
| K241661 | 2024-07-10 | Sleepnet Corporation | Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face V 摘要 |
| K233415 | 2024-07-02 | Remsleep Holdings | DELTAWAVE Nasal Pillows System 摘要 |
| K241469 | 2024-06-15 | Sleepnet Corporation | iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask 摘要 |
| K230476 | 2023-10-19 | Resmed Pty Ltd (Registration Number: 3 | Oran Park Mask 摘要 |
FDA 官方分类页： BZD
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。