LAP-iX 吸引冲洗器
K号: K200638 · 2020-04-03
广告
决定日期2020-04-03
产品代码HET
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
LAP-iX Suction Irrigation is the device name listed in this FDA 510(k) record. The listed applicant is Sejong Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-04-03 under 510(k) number K200638. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the LAP-iX Suction Irrigation?
LAP-iX Suction Irrigation is a medical device that received FDA 510(k) clearance on 2020-04-03. The listed applicant is Sejong Medical Co., Ltd.. The 510(k) number is K200638.
When did LAP-iX Suction Irrigation receive FDA 510(k) clearance?
LAP-iX Suction Irrigation received FDA 510(k) clearance on 2020-04-03, under 510(k) number K200638.
Who is the listed applicant for LAP-iX Suction Irrigation?
The FDA 510(k) record lists Sejong Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LAP-iX Suction Irrigation?
The FDA product code for LAP-iX Suction Irrigation is HET.
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Sejong Medical 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。
相关器械（代码：HET）
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。
K250939SIRIUS 内窥镜系统 (PR-SI-1230)Precision Robotics (Hong Kong) LimitedK243821i-CutA.M.I. Agency For Medical Innovations GmbHK221642SIRIUS 内窥镜系统Precision Robotics (Hong Kong) LimitedK210116视频内镜系统，3D视频内镜系统Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.K210104SurroundScope系统270surgical , Ltd.
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