VereSee 光学 Veres 针系统
K号: K232464 · 2024-05-02
广告
决定日期2024-05-02
产品代码HIF
咨询委员会OB
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
VereSee Optical Veres Needle System is the device name listed in this FDA 510(k) record. The listed applicant is Freyja Healthcare, LLC. It received FDA 510(k) clearance on 2024-05-02 under 510(k) number K232464. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the VereSee Optical Veres Needle System?
VereSee Optical Veres Needle System is a medical device that received FDA 510(k) clearance on 2024-05-02. The listed applicant is Freyja Healthcare, LLC. The 510(k) number is K232464.
When did VereSee Optical Veres Needle System receive FDA 510(k) clearance?
VereSee Optical Veres Needle System received FDA 510(k) clearance on 2024-05-02, under 510(k) number K232464.
Who is the listed applicant for VereSee Optical Veres Needle System?
FDA 510(k)记录中列出Freyja Healthcare, LLC为申请人。这本身并不足以确立该设备制造商的身份。
What is the FDA product code for VereSee Optical Veres Needle System?
The FDA product code for VereSee Optical Veres Needle System is HIF.
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Freyja Healthcare, LLC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：HIF）
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。
K260209ENDOFLATOR+；智能烟雾排放器Karl Storz SE & CO. KGK252584充气器（wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C）Weyo Surgical Technology , Ltd.K252318充气器（OPTO-IFL1000）Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KGK242772AirSurgN充气器（10030/AirSurgN）SmartsurgN, Inc.K243527高流量充气单元（UHI-4）Olympus Medical Systems Corporation
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。
广告