EM ENT 导航吸引器
K号: K153555 · 2016-04-07
广告
决定日期2016-04-07
产品代码PGW
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
EM ENT Navigated Suctions is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2016-04-07 under 510(k) number K153555. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EM ENT Navigated Suctions?
EM ENT Navigated Suctions is a medical device that received FDA 510(k) clearance on 2016-04-07. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K153555.
When did EM ENT Navigated Suctions receive FDA 510(k) clearance?
EM ENT Navigated Suctions received FDA 510(k) clearance on 2016-04-07, under 510(k) number K153555.
Who is the listed applicant for EM ENT Navigated Suctions?
The FDA 510(k) record lists Medtronic Navigation, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EM ENT Navigated Suctions?
The FDA product code for EM ENT Navigated Suctions is PGW.
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Medtronic Navigation, Inc.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：PGW）
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。
K262235ApexCut™ 自动电磁跟踪刀片（187BL4012EM）；ApexCut™ 自动电磁跟踪刀片（187BL4040EM）；ApexCut™ 自动电磁跟踪刀片（187BL4060EM）；ApexCut™ 自动电磁跟踪刀片（187BL2975EM）；ApexCut™ 自动电磁跟踪刀片（187BL3590EM）；ApexCut™ 自动电磁跟踪刀片（187BL4000LEM）Medtronic Xomed, Inc.K261540Cube 4D 导航系统，VirtuEye ProFiagon GmbHK253395Stealth AXiS™ ENT临床应用Medtronic Navigation, Inc.K243053Navient 图像引导导航系统 (ENT) (955-NC-NC)ClaronavK231862TruDi® 导航系统 V3（FG-2000-00）Acclarent, Inc.K223734ENT EMBrainlab AG
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