NEXA™ NPWT 系统
K号: K241515 · 2024-07-26
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决定日期2024-07-26
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
NEXA™ NPWT System is the device name listed in this FDA 510(k) record. The listed applicant is Nexa Medical Limited. It received FDA 510(k) clearance on 2024-07-26 under 510(k) number K241515. 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 NEXA™ NPWT System?
NEXA™ NPWT System is a medical device that received FDA 510(k) clearance on 2024-07-26. The listed applicant is Nexa Medical Limited. The 510(k) number is K241515.
When did NEXA™ NPWT System receive FDA 510(k) clearance?
NEXA™ NPWT System received FDA 510(k) clearance on 2024-07-26, under 510(k) number K241515.
Who is the listed applicant for NEXA™ NPWT System?
The FDA 510(k) record lists Nexa Medical Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NEXA™ NPWT System?
The FDA product code for NEXA™ NPWT System 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。
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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