FDA 510(k)

MiiS Horus Scope DPT 100

K号: K181260 · 2019-06-21

申请人Medimaging Integrated Solution, Inc (Miis)

决定日期2019-06-21

产品代码HKX

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决定实质等同

器械摘要

MiiS Horus Scope DPT 100 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 2019-06-21 under 510(k) number K181260. The device is classified under product code HKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MiiS Horus Scope DPT 100?

MiiS Horus Scope DPT 100 is a medical device that received FDA 510(k) clearance on 2019-06-21. The listed applicant is Medimaging Integrated Solution, Inc (Miis). The 510(k) number is K181260.

When did MiiS Horus Scope DPT 100 receive FDA 510(k) clearance?

MiiS Horus Scope DPT 100 received FDA 510(k) clearance on 2019-06-21, under 510(k) number K181260.

Who is the listed applicant for MiiS Horus Scope DPT 100?

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 Scope DPT 100?

The FDA product code for MiiS Horus Scope DPT 100 is HKX.

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 K193188MiiS Horus 眼前部摄像头 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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