FDA 510(k)

BrightMatter Guide with BrightMatter Pointer

K号: K160523 · 2016-06-24

决定日期2016-06-24

产品代码HAW

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决定实质等同

器械摘要

BrightMatter Guide with BrightMatter Pointer is the device name listed in this FDA 510(k) record. The listed applicant is Synaptive Medical, Inc.. It received FDA 510(k) clearance on 2016-06-24 under 510(k) number K160523. 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 BrightMatter Guide with BrightMatter Pointer?

BrightMatter Guide with BrightMatter Pointer is a medical device that received FDA 510(k) clearance on 2016-06-24. The listed applicant is Synaptive Medical, Inc.. The 510(k) number is K160523.

When did BrightMatter Guide with BrightMatter Pointer receive FDA 510(k) clearance?

BrightMatter Guide with BrightMatter Pointer received FDA 510(k) clearance on 2016-06-24, under 510(k) number K160523.

Who is the listed applicant for BrightMatter Guide with BrightMatter Pointer?

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

What is the FDA product code for BrightMatter Guide with BrightMatter Pointer?

The FDA product code for BrightMatter Guide with BrightMatter Pointer is HAW.

列明Synaptive Medical, 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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