FDA 510(k)

StealthStation S8颅骨v2.0

K号: K212397 · 2021-12-22

决定日期2021-12-22

产品代码HAW

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决定实质等同

器械摘要

StealthStation S8 Cranial v2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K212397. 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 StealthStation S8 Cranial v2.0?

StealthStation S8 Cranial v2.0 is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Medtronic Navigation. The 510(k) number is K212397.

When did StealthStation S8 Cranial v2.0 receive FDA 510(k) clearance?

StealthStation S8 Cranial v2.0 received FDA 510(k) clearance on 2021-12-22, under 510(k) number K212397.

Who is the listed applicant for StealthStation S8 Cranial v2.0?

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

What is the FDA product code for StealthStation S8 Cranial v2.0?

The FDA product code for StealthStation S8 Cranial v2.0 is HAW.

列明Medtronic Navigation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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