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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)
288 件

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
K2601712026-08-14BMC Medical Co., Ltd.Portable Oxygen Concentrator (PO1 5B, PO1 6B) 摘要
K2523992026-06-17Honsun (Nantong) Co., Ltd.Portable Oxygen Concentrator 摘要
K2529652026-05-29Oxytek Medical Technology Co., Ltd.Oxygen Concentrator (OX-5A, OX-5C) 摘要
K2524072026-04-23Mv Life, LLCOxyGo Portable Oxygen Concentrator (1400-7000) 摘要
K2535492026-03-26Devilbiss Healthcare, LLCDeVilbiss 5 Liter Oxygen Concentrator (555) 摘要
K2515342025-12-29Foshan Kycare Medical Equipment Co., LOxygen Concentrator (J10A) 摘要
K2517642025-12-22Qingdao Kingon Medical Science and TecOxygen Concentrator-P2-O5E 摘要
K2526162025-12-22Shenzhen Homed Medical Device Co., LtdPortable oxygen concentrator (JLO-190P) 摘要
K2522682025-12-16Shenzhen Harveymed Technology Co., LtdV series portable oxygen concentrator (V5, V5C, V6, 摘要
K2508052025-12-09Devilbiss Healthcare, LLCDeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060A 摘要
K2516072025-11-21Foshan Kycare Medical Equipment Co., LOxygen Concentrator (J5A) 摘要
K2438332025-09-29Longfian Scitech Co., Ltd.Portable oxygen concentrator (JAY-1000P) 摘要
K2506252025-08-27Nanjing Yinuoji Medical Technology Co.Portable oxygen concentrator (W-R1(MAX)); Portable 摘要
K2511302025-08-21Jiangsu Jumao X-Care Medical EquipmentPortable Oxygen Concentrator (JM-P50A) 摘要
K2506712025-07-11Caire, Inc.FreeStyle Comfort (AS200 / FreeStyle Comfort) 摘要
K2427362025-06-05Jiangsu Yuyue Medical Equipment & SuppPortable Oxygen Concentrator (Spirit-3) 摘要
K2427182025-02-28Qingdao Kingon Medical Science and TecPortable Oxygen Concentrator (P2-TOC) 摘要
K2405612024-12-06Molecular Products , Ltd.Rugged Oxygen Generator (ROG) (RO01-00001) 摘要
K2408402024-12-06Foshan Care Medical Technology Co., LtOxygen Concentrator (ZY-10AB/115) 摘要
K2309692023-11-09Jiangsu Jumao X-Care Medical EquipmentOxygen Concentrator 摘要
K2307022023-10-18Qingdao Kingon Medical Science and TecPortable Oxygen Concentrator (Model: P2-S4, P2-S3,P2 摘要
K2237402023-10-05Jiangsu Konsung Bio-Medical Science anOxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)
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。