CapsoCam Plus (SV-3) 球囊内窥镜系统
K号: K161773 · 2016-10-21
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器械摘要
CapsoCam Plus (SV-3) Capsule Endoscope 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 2016-10-21 under 510(k) number K161773. 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 Endoscope System?
CapsoCam Plus (SV-3) Capsule Endoscope System is a medical device that received FDA 510(k) clearance on 2016-10-21. The listed applicant is CapsoVision, Inc.. The 510(k) number is K161773.
When did CapsoCam Plus (SV-3) Capsule Endoscope System receive FDA 510(k) clearance?
CapsoCam Plus (SV-3) Capsule Endoscope System received FDA 510(k) clearance on 2016-10-21, under 510(k) number K161773.
Who is the listed applicant for CapsoCam Plus (SV-3) Capsule Endoscope System?
The FDA 510(k) record lists CapsoVision, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CapsoCam Plus (SV-3) Capsule Endoscope System?
The FDA product code for CapsoCam Plus (SV-3) Capsule Endoscope System is NEZ.
相关临床试验
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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。
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