FDA 510(k)

Brainlab 兼容 K2M 导航仪器

K号: K192911 · 2019-11-14

决定日期2019-11-14

产品代码OLO

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决定实质等同

器械摘要

Brainlab Compatible 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 2019-11-14 under 510(k) number K192911. 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 Brainlab Compatible K2M Navigation Instruments?

Brainlab Compatible K2M Navigation Instruments is a medical device that received FDA 510(k) clearance on 2019-11-14. The listed applicant is K2m, Inc.. The 510(k) number is K192911.

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

Brainlab Compatible K2M Navigation Instruments received FDA 510(k) clearance on 2019-11-14, under 510(k) number K192911.

Who is the listed applicant for Brainlab Compatible 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 Brainlab Compatible K2M Navigation Instruments?

The FDA product code for Brainlab Compatible K2M Navigation Instruments is OLO.

列明K2m, Inc.为申报人的其他记录

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