NaviCam Small Bowel Capsule Endoscopy System
K号: K221590 · 2022-12-02
广告
决定日期2022-12-02
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
NaviCam Small Bowel Capsule Endoscopy System is the device name listed in this FDA 510(k) record. The listed applicant is Ankon Technologies Co., Ltd.. It received FDA 510(k) clearance on 2022-12-02 under 510(k) number K221590. 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 NaviCam Small Bowel Capsule Endoscopy System?
NaviCam Small Bowel Capsule Endoscopy System is a medical device that received FDA 510(k) clearance on 2022-12-02. The listed applicant is Ankon Technologies Co., Ltd.. The 510(k) number is K221590.
When did NaviCam Small Bowel Capsule Endoscopy System receive FDA 510(k) clearance?
NaviCam Small Bowel Capsule Endoscopy System received FDA 510(k) clearance on 2022-12-02, under 510(k) number K221590.
Who is the listed applicant for NaviCam Small Bowel Capsule Endoscopy System?
The FDA 510(k) record lists Ankon Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NaviCam Small Bowel Capsule Endoscopy System?
The FDA product code for NaviCam Small Bowel 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。
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