AirSeal iFS系统；AirSeal dV解决方案
K号: K230239 · 2023-09-20
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决定日期2023-09-20
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
AirSeal iFS System; AirSeal dV Solution is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2023-09-20 under 510(k) number K230239. 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 AirSeal iFS System; AirSeal dV Solution?
AirSeal iFS System; AirSeal dV Solution is a medical device that received FDA 510(k) clearance on 2023-09-20. The listed applicant is Conmed Corporation. The 510(k) number is K230239.
When did AirSeal iFS System; AirSeal dV Solution receive FDA 510(k) clearance?
AirSeal iFS System; AirSeal dV Solution received FDA 510(k) clearance on 2023-09-20, under 510(k) number K230239.
Who is the listed applicant for AirSeal iFS System; AirSeal dV Solution?
The FDA 510(k) record lists Conmed Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AirSeal iFS System; AirSeal dV Solution?
The FDA product code for AirSeal iFS System; AirSeal dV Solution 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Conmed 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.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。
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