FDA 510(k)

K2M 导航仪器

K号: K201006 · 2020-08-07

决定日期2020-08-07

产品代码OLO

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决定实质等同

器械摘要

K2M Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2020-08-07 under 510(k) number K201006. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the K2M Navigation Instruments?

K2M Navigation Instruments is a medical device that received FDA 510(k) clearance on 2020-08-07. The listed applicant is K2m, Inc.. The 510(k) number is K201006.

When did K2M Navigation Instruments receive FDA 510(k) clearance?

K2M Navigation Instruments received FDA 510(k) clearance on 2020-08-07, under 510(k) number K201006.

Who is the listed applicant for K2M Navigation Instruments?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K2M Navigation Instruments?

The FDA product code for K2M Navigation Instruments is OLO.

列明K2m, 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。

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