便携式制氧机
K号: K252399 · 2026-06-17
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决定日期2026-06-17
产品代码CAW
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同
器械摘要
Portable Oxygen Concentrator is the device name listed in this FDA 510(k) record. The listed applicant is Honsun (Nantong) Co., Ltd.. It received FDA 510(k) clearance on 2026-06-17 under 510(k) number K252399. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Portable Oxygen Concentrator?
Portable Oxygen Concentrator is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Honsun (Nantong) Co., Ltd.. The 510(k) number is K252399.
When did Portable Oxygen Concentrator receive FDA 510(k) clearance?
Portable Oxygen Concentrator received FDA 510(k) clearance on 2026-06-17, under 510(k) number K252399.
Who is the listed applicant for Portable Oxygen Concentrator?
FDA 510(k)记录将江苏恒生医疗器械有限公司列为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for Portable Oxygen Concentrator?
The FDA product code for Portable Oxygen Concentrator is CAW.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Honsun (Nantong) Co., Ltd.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：CAW）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K254289便携式制氧机（OX-1A-E，OX-1B）Oxytek Medical Technology Co., Ltd.K260171便携式氧气浓缩器（PO1 5B，PO1 6B）BMC Medical Co., Ltd.K252965氧气浓缩器 (OX-5A, OX-5C)Oxytek Medical Technology Co., Ltd.K252407OxyGo便携式氧气浓缩器（1400-7000）Mv Life, LLCK253549DeVilbiss 5 升制氧机（555）Devilbiss Healthcare, LLCK251534氧气浓缩器 (J10A)Foshan Kycare Medical Equipment Co., Ltd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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