Longterm NPWT泡沫敷料套装
K号: K182458 · 2019-05-23
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决定日期2019-05-23
产品代码OMP
咨询委员会SU
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决定实质等同
器械摘要
Longterm NPWT Foam Dressing Kit is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-05-23 under 510(k) number K182458. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Longterm NPWT Foam Dressing Kit?
Longterm NPWT Foam Dressing Kit is a medical device that received FDA 510(k) clearance on 2019-05-23. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. The 510(k) number is K182458.
When did Longterm NPWT Foam Dressing Kit receive FDA 510(k) clearance?
Longterm NPWT Foam Dressing Kit received FDA 510(k) clearance on 2019-05-23, under 510(k) number K182458.
Who is the listed applicant for Longterm NPWT Foam Dressing Kit?
FDA 510(k)记录将浙江龙泰医疗科技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 Longterm NPWT Foam Dressing Kit?
The FDA product code for Longterm NPWT Foam Dressing Kit is OMP.
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Zhejiang Longterm Medical Technology 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：OMP）
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。
K261338RENASYS DYNAFLOW 套件（66807741）Smith & Nephew Medical, Ltd.K253263ConvaVAC™ 负压伤口治疗系统Convatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT 罐 500-毫升 (CPC-500)Cork MedicalK254019伤口基因NPWT系统Bechtel Medical, Inc.
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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