充气器
K号: K222812 · 2023-05-16
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决定日期2023-05-16
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
Insufflator is the device name listed in this FDA 510(k) record. The listed applicant is Scivita Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-05-16 under 510(k) number K222812. 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 Insufflator?
Insufflator is a medical device that received FDA 510(k) clearance on 2023-05-16. The listed applicant is Scivita Medical Technology Co., Ltd.. The 510(k) number is K222812.
When did Insufflator receive FDA 510(k) clearance?
Insufflator received FDA 510(k) clearance on 2023-05-16, under 510(k) number K222812.
Who is the listed applicant for Insufflator?
FDA 510(k)记录将斯奇维塔医疗科技有限公司列为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for Insufflator?
The FDA product code for Insufflator 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Scivita Medical Technology Co., Ltd.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。
K262552一次性使用柔性输尿管镜（一次性使用柔性输尿管镜：SUV-5C-B）K251338胆管镜可视化系统（一次性视频胆管镜：SCV-P-01G，SCV-P-02G；全高清可视化内镜图像处理器：HDVS-S300A，HDVS-S300B，HDVS-S300C，HDVS-S300D）K243708泌尿外科视频内镜系统（一次性使用柔性输尿管镜：SUV-1A-B，SUV-1A-P，SUV-2A-B，SUV-2A-P，SUV-2B-B，SUB-2B-P，SUV-2C-B，SUV-2C-P；一次性使用柔性膀胱镜：SUV-1D-B，SUV-1D-P；内镜图像处理器：HDVS-S100A，HDVS-S100D。）K250210Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))K240289全高清内镜图像处理器（HDVS-S200A，HDVS-S200B，HDVS-S200C，HDVS-S200D）K240192一次性使用提取篮
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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