FDA 510(k)

MiiS Horus 眼前部摄像头

K号: K193188 · 2020-01-14

申请人Medimaging Integrated Solution, Inc (Miis)

决定日期2020-01-14

产品代码HJO

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决定实质等同

器械摘要

MiiS Horus Eye Anterior Camera is the device name listed in this FDA 510(k) record. The listed applicant is Medimaging Integrated Solution, Inc (Miis). It received FDA 510(k) clearance on 2020-01-14 under 510(k) number K193188. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MiiS Horus Eye Anterior Camera?

MiiS Horus Eye Anterior Camera is a medical device that received FDA 510(k) clearance on 2020-01-14. The listed applicant is Medimaging Integrated Solution, Inc (Miis). The 510(k) number is K193188.

When did MiiS Horus Eye Anterior Camera receive FDA 510(k) clearance?

MiiS Horus Eye Anterior Camera received FDA 510(k) clearance on 2020-01-14, under 510(k) number K193188.

Who is the listed applicant for MiiS Horus Eye Anterior Camera?

The FDA 510(k) record lists Medimaging Integrated Solution, Inc (Miis) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MiiS Horus Eye Anterior Camera?

The FDA product code for MiiS Horus Eye Anterior Camera is HJO.

列明Medimaging Integrated Solution, Inc (Miis)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。

K253217MiiS Horus 眼镜镜片（EJA 100）；MiiS Horus 内窥镜显示系统 - 平板（EDS 500）；MiiS Horus 内窥镜显示系统 - 视频盒（EVS 700）K234113MiiS Horus 支气管镜；MiiS Horus 内窥镜显示系统 - 平板；MiiS Horus 内窥镜显示系统 - 视频盒 K223926VersaVue 单次使用柔性膀胱镜，VersaVue 平板电脑，和 VersaVue 视频盒 K214050ENT 鼻咽镜及其附件 K181260MiiS Horus Scope DPT 100 K170470数字眼前端摄像机

查看所有 7 个设备 →

官方来源

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