NEXA 负压伤口治疗系统
K号: K162610 · 2017-06-08
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决定日期2017-06-08
产品代码OMP
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
NEXA Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Nexa Medical , Ltd.. It received FDA 510(k) clearance on 2017-06-08 under 510(k) number K162610. 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 Negative Pressure Wound Therapy System?
NEXA Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2017-06-08. The listed applicant is Nexa Medical , Ltd.. The 510(k) number is K162610.
When did NEXA Negative Pressure Wound Therapy System receive FDA 510(k) clearance?
NEXA Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2017-06-08, under 510(k) number K162610.
Who is the listed applicant for NEXA Negative Pressure Wound Therapy System?
The FDA 510(k) record lists Nexa Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NEXA Negative Pressure Wound Therapy System?
The FDA product code for NEXA Negative Pressure Wound Therapy 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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