CapsoCam Plus (SV-3) 球囊内镜系统
K号: K242643 · 2024-12-04
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决定日期2024-12-04
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 Plus (SV-3) Capsule Endoscopy System is the device name listed in this FDA 510(k) record. The listed applicant is CapsoVision, Inc.. It received FDA 510(k) clearance on 2024-12-04 under 510(k) number K242643. 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 Plus (SV-3) Capsule Endoscopy System?
CapsoCam Plus (SV-3) Capsule Endoscopy System is a medical device that received FDA 510(k) clearance on 2024-12-04. The listed applicant is CapsoVision, Inc.. The 510(k) number is K242643.
When did CapsoCam Plus (SV-3) Capsule Endoscopy System receive FDA 510(k) clearance?
CapsoCam Plus (SV-3) Capsule Endoscopy System received FDA 510(k) clearance on 2024-12-04, under 510(k) number K242643.
Who is the listed applicant for CapsoCam Plus (SV-3) Capsule Endoscopy System?
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 Plus (SV-3) Capsule Endoscopy System?
The FDA product code for CapsoCam Plus (SV-3) Capsule Endoscopy System 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.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)K221590NaviCam Small Bowel Capsule Endoscopy SystemAnkon Technologies Co., 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。
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