FDA 510(k)

ClearPoint 系统及附件

K号: K200079 · 2020-02-13

决定日期2020-02-13

产品代码HAW

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决定实质等同

器械摘要

ClearPoint System and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Mri Interventions, Inc.. It received FDA 510(k) clearance on 2020-02-13 under 510(k) number K200079. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ClearPoint System and Accessories?

ClearPoint System and Accessories is a medical device that received FDA 510(k) clearance on 2020-02-13. The listed applicant is Mri Interventions, Inc.. The 510(k) number is K200079.

When did ClearPoint System and Accessories receive FDA 510(k) clearance?

ClearPoint System and Accessories received FDA 510(k) clearance on 2020-02-13, under 510(k) number K200079.

Who is the listed applicant for ClearPoint System and Accessories?

The FDA 510(k) record lists Mri Interventions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClearPoint System and Accessories?

The FDA product code for ClearPoint System and Accessories is HAW.

列明Mri Interventions, 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。

K191701Arcus 头部固定框架 K191400Voyager 轨迹阵列指南（V-TAG）K181731MR 兼容吸引器套装 K181195ClearPoint 系统 K171257ClearPoint 系统 K160129MRII颅骨钻和附件

查看所有 8 个设备 →

官方来源

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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。