甘先生 · haixiao@sungolytest.com · 158 2169 5110 微信 · 132 4819 8029罗先生 · jun.luo@sungoglobal.com · 177 5560 4650 微信

CAW

Generator, Oxygen, Portable

产品代码
CAW
器械名称
Generator, Oxygen, Portable
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 868.5440
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)
22 件
其中 Summary 已存档
19 份,可直接下载
FDA 历史累计 510(k)
288 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)(22 件)

数据窗口为最近三年。最新一件:2026-08-14。

510(k) 号批准日期申请人器械名称摘要
K2601712026-08-14BMC Medical Co., Ltd.Portable Oxygen Concentrator (PO1 5B, PO1 6B)PDF
K2523992026-06-17Honsun (Nantong) Co., Ltd.Portable Oxygen ConcentratorPDF
K2529652026-05-29Oxytek Medical Technology Co., Ltd.Oxygen Concentrator (OX-5A, OX-5C)PDF
K2524072026-04-23Mv Life, LLCOxyGo Portable Oxygen Concentrator (1400-7000)PDF
K2535492026-03-26Devilbiss Healthcare, LLCDeVilbiss 5 Liter Oxygen Concentrator (555)PDF
K2515342025-12-29Foshan Kycare Medical Equipment Co., L…Oxygen Concentrator (J10A)PDF
K2517642025-12-22Qingdao Kingon Medical Science and Tec…Oxygen Concentrator-P2-O5EPDF
K2526162025-12-22Shenzhen Homed Medical Device Co., Ltd…Portable oxygen concentrator (JLO-190P)PDF
K2522682025-12-16Shenzhen Harveymed Technology Co., Ltd…V series portable oxygen concentrator (V5, V5C, V6, …PDF
K2508052025-12-09Devilbiss Healthcare, LLCDeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060A…PDF
K2516072025-11-21Foshan Kycare Medical Equipment Co., L…Oxygen Concentrator (J5A)PDF
K2438332025-09-29Longfian Scitech Co., Ltd.Portable oxygen concentrator (JAY-1000P)PDF
K2506252025-08-27Nanjing Yinuoji Medical Technology Co.…Portable oxygen concentrator (W-R1(MAX)); Portable …PDF
K2511302025-08-21Jiangsu Jumao X-Care Medical Equipment…Portable Oxygen Concentrator (JM-P50A)PDF
K2506712025-07-11Caire, Inc.FreeStyle Comfort (AS200 / FreeStyle Comfort)PDF
K2427362025-06-05Jiangsu Yuyue Medical Equipment & Supp…Portable Oxygen Concentrator (Spirit-3)PDF
K2427182025-02-28Qingdao Kingon Medical Science and Tec…Portable Oxygen Concentrator (P2-TOC)FDA
K2405612024-12-06Molecular Products , Ltd.Rugged Oxygen Generator (ROG) (RO01-00001)PDF
K2408402024-12-06Foshan Care Medical Technology Co., Lt…Oxygen Concentrator (ZY-10AB/115)PDF
K2309692023-11-09Jiangsu Jumao X-Care Medical Equipment…Oxygen ConcentratorFDA
K2307022023-10-18Qingdao Kingon Medical Science and Tec…Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2…PDF
K2237402023-10-05Jiangsu Konsung Bio-Medical Science an…Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)—

其中 19 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: CAW
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。