VT·One，VT·One 60天
K号: K161410 · 2016-10-13
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决定日期2016-10-13
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
VT·One, VT·One 60days is the device name listed in this FDA 510(k) record. The listed applicant is Carilex Medical, Inc.. It received FDA 510(k) clearance on 2016-10-13 under 510(k) number K161410. 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 VT·One, VT·One 60days?
VT·One, VT·One 60days is a medical device that received FDA 510(k) clearance on 2016-10-13. The listed applicant is Carilex Medical, Inc.. The 510(k) number is K161410.
When did VT·One, VT·One 60days receive FDA 510(k) clearance?
VT·One, VT·One 60days received FDA 510(k) clearance on 2016-10-13, under 510(k) number K161410.
Who is the listed applicant for VT·One, VT·One 60days?
The FDA 510(k) record lists Carilex Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VT·One, VT·One 60days?
The FDA product code for VT·One, VT·One 60days is OMP.
列明Carilex Medical, Inc.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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