RENASYS Y 连接器；RENASYS TOUCH
K号: K181204 · 2019-01-10
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决定日期2019-01-10
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
RENASYS Y-Connector; RENASYS TOUCH is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2019-01-10 under 510(k) number K181204. 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 RENASYS Y-Connector; RENASYS TOUCH?
RENASYS Y-Connector; RENASYS TOUCH is a medical device that received FDA 510(k) clearance on 2019-01-10. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K181204.
When did RENASYS Y-Connector; RENASYS TOUCH receive FDA 510(k) clearance?
RENASYS Y-Connector; RENASYS TOUCH received FDA 510(k) clearance on 2019-01-10, under 510(k) number K181204.
Who is the listed applicant for RENASYS Y-Connector; RENASYS TOUCH?
The FDA 510(k) record lists Smith & Nephew Medical Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RENASYS Y-Connector; RENASYS TOUCH?
The FDA product code for RENASYS Y-Connector; RENASYS TOUCH is OMP.
相关临床试验
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列明Smith & Nephew Medical Limited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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