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BZD

Ventilator, Non-Continuous (Respirator)

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)
26 件
其中 Summary 已存档
23 份,可直接下载
FDA 历史累计 510(k)
461 件(全部年份;本站只收录近三年的明细)

该代码近三年的 510(k)(26 件)

数据窗口为最近三年。最新一件:2026-07-23。

510(k) 号批准日期申请人器械名称摘要
K2530442026-07-23Resvent Medical Technology Co., Ltd.RXiBreeze PAP System (RXiBreeze 20C)PDF
K2535532026-06-04Resmed CorpOrionPDF
K2541042026-05-27Resmed CorpResScan EssentialsFDA
K2519202026-05-21Dcstar, Inc.Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full…PDF
K2531662026-04-29BMC Medical Co., Ltd.F6S Full Face Mask (F6S); P6S Nasal Pillows Interfac…PDF
K2523382026-04-17Somnetics International, Inc. (Dba Tra…MySleepDashPDF
K2518472026-01-15Sleepnet CorporationSleepnet Arie Full Face Vented Mask; Sleepnet Arie N…PDF
K2539392026-01-07RemSleep Holdings, Inc.DeltaWave Nasal Pillow SystemPDF
K2517702025-12-15Sleepres, Inc.SleepRes PAP SystemPDF
K2516572025-12-05Resmed CorpPersonalized Therapy Comfort Settings (PTCS)PDF
K2435832025-06-18Fisher & Paykel Healthcare LimitedF&P Nova Nasal MaskPDF
K2506242025-05-28Resmed CorpmyAirPDF
K2430232025-05-23Wellell, Inc.WiZARD 520 Full Face MaskPDF
K2425472025-05-19Resmed Pty , Ltd.AirFit F20 Mask System; AirFit F20 NM Mask SystemPDF
K2429352025-01-15BMC Medical Co., Ltd.Respiration Data Management Software (PAP Link PC)PDF
K2432252024-12-31Genadyne Biotechnologies, Inc.Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal …PDF
K2418302024-10-18Sleepnet CorporationMojo Full Face Vented Mask; Veraseal 2 Full Face Ven…PDF
K2419392024-09-27Resmed CorpEasyCare Tx 2PDF
K2412162024-09-26Resmed CorpmyAirPDF
K2341342024-09-24Resmed Pty Ltd (Registration Number: 3…AirFit F30i Mask System; AirFit F30i NM Mask System;…PDF
K2338292024-08-23Fisher and Paykel Healthcare LimitedNova Micro Pillows Mask Small A Model (NVP1SA); Nova…PDF
K2335552024-07-31Philips RespironicsAF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal…FDA
K2416612024-07-10Sleepnet CorporationMojo 2 Full Face Vented Mask; Veraseal 3 Full Face V…FDA
K2334152024-07-02Remsleep HoldingsDELTAWAVE Nasal Pillows SystemPDF
K2414692024-06-15Sleepnet CorporationiQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented MaskPDF
K2304762023-10-19Resmed Pty Ltd (Registration Number: 3…Oran Park MaskPDF

其中 23 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

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。