FDA 510(k)

MiroCam 纤维内窥镜系统

K号: K170438 · 2018-01-30

决定日期2018-01-30

产品代码NEZ

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决定实质等同

器械摘要

MiroCam Capsule Endoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Intromedic Co., Ltd.. It received FDA 510(k) clearance on 2018-01-30 under 510(k) number K170438. 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 MiroCam Capsule Endoscope System?

MiroCam Capsule Endoscope System is a medical device that received FDA 510(k) clearance on 2018-01-30. The listed applicant is Intromedic Co., Ltd.. The 510(k) number is K170438.

When did MiroCam Capsule Endoscope System receive FDA 510(k) clearance?

MiroCam Capsule Endoscope System received FDA 510(k) clearance on 2018-01-30, under 510(k) number K170438.

Who is the listed applicant for MiroCam Capsule Endoscope System?

The FDA 510(k) record lists Intromedic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MiroCam Capsule Endoscope System?

The FDA product code for MiroCam Capsule Endoscope System is NEZ.

列明Intromedic Co., Ltd.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。

K252617MiroCam® 纤维内窥镜系统 K180732MiroCam 纤维内窥镜系统

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 Corporation K230991PillCam SB 3 胶囊内镜系统，PillCam 软件 9.0EGiven Imaging Ltd. (Medtronic)

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