高流量充气单元（UHI-4）
K号: K243527 · 2025-01-13
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决定日期2025-01-13
产品代码HIF
咨询委员会OB
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决定实质等同
器械摘要
High Flow Insufflation Unit (UHI-4) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-01-13 under 510(k) number K243527. 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 High Flow Insufflation Unit (UHI-4)?
High Flow Insufflation Unit (UHI-4) is a medical device that received FDA 510(k) clearance on 2025-01-13. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K243527.
When did High Flow Insufflation Unit (UHI-4) receive FDA 510(k) clearance?
High Flow Insufflation Unit (UHI-4) received FDA 510(k) clearance on 2025-01-13, under 510(k) number K243527.
Who is the listed applicant for High Flow Insufflation Unit (UHI-4)?
FDA 510(k)记录显示，Olympus Medical Systems Corporation为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for High Flow Insufflation Unit (UHI-4)?
The FDA product code for High Flow Insufflation Unit (UHI-4) 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Olympus Medical Systems Corporation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.K242536TauTona 腹腔充气辅助装置（TPAD）Tautona Group
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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