Endomat Select
K号: K180735 · 2018-10-31
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决定日期2018-10-31
产品代码HIG
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
Endomat Select is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2018-10-31 under 510(k) number K180735. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Endomat Select?
Endomat Select is a medical device that received FDA 510(k) clearance on 2018-10-31. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K180735.
When did Endomat Select receive FDA 510(k) clearance?
Endomat Select received FDA 510(k) clearance on 2018-10-31, under 510(k) number K180735.
Who is the listed applicant for Endomat Select?
FDA 510(k)记录中列出Karl Storz SE & CO. KG为申请人。这本身并不能确立该设备的制造商。
What is the FDA product code for Endomat Select?
The FDA product code for Endomat Select is HIG.
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Karl Storz SE & CO. KG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：HIG）
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。
K261706Endomat Select (UP220)KARL STORZ SE & CO. KGK251273Asurys 流体管理系统Boston Scientific CorporationK240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)Hologic, Inc.K210628X-FLO 液体管理系统Thermedx, LLCK201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KGK180825Fluent Fluid Management SystemHologic, 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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