CapsoCam (SV-1)
K号: K151635 · 2016-02-09
广告
决定日期2016-02-09
产品代码NEZ
咨询委员会GU
请注意,由于您只提供了“GU”这个词,我无法提供完整的翻译。如果您能提供完整的句子或段落,我将能够为您提供准确的翻译。
决定实质等同
器械摘要
CapsoCam (SV-1) is the device name listed in this FDA 510(k) record. The listed applicant is CapsoVision, Inc.. It received FDA 510(k) clearance on 2016-02-09 under 510(k) number K151635. The device is classified under product code NEZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CapsoCam (SV-1)?
CapsoCam (SV-1) is a medical device that received FDA 510(k) clearance on 2016-02-09. The listed applicant is CapsoVision, Inc.. The 510(k) number is K151635.
When did CapsoCam (SV-1) receive FDA 510(k) clearance?
CapsoCam (SV-1) received FDA 510(k) clearance on 2016-02-09, under 510(k) number K151635.
Who is the listed applicant for CapsoCam (SV-1)?
FDA 510(k)记录中列出CapsoVision,Inc.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 CapsoCam (SV-1)?
The FDA product code for CapsoCam (SV-1) is NEZ.
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CapsoVision, 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:NEZ)
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。
K252617MiroCam® 纤维内窥镜系统Intromedic Co., Ltd.K252480CE Deliver (DLV)CapsoVision, Inc.K242643CapsoCam Plus (SV-3) 球囊内镜系统CapsoVision, Inc.K240276PillCam™ Genius SB 系统,配备 PillCam 软件 v9.7 和 PillCam Cloud Reader 软件Given Imaging Ltd. (D.B.A. Medtronic)K233229NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam TetherAnx Robotica CorporationK230991PillCam SB 3 胶囊内镜系统,PillCam 软件 9.0EGiven Imaging Ltd. (Medtronic)
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