FDA 510(k)

BrightMatter Plan 1.6.0

K号: K180394 · 2018-03-09

决定日期2018-03-09

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

BrightMatter Plan 1.6.0 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 2018-03-09 under 510(k) number K180394. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BrightMatter Plan 1.6.0?

BrightMatter Plan 1.6.0 is a medical device that received FDA 510(k) clearance on 2018-03-09. The listed applicant is Synaptive Medical, Inc.. The 510(k) number is K180394.

When did BrightMatter Plan 1.6.0 receive FDA 510(k) clearance?

BrightMatter Plan 1.6.0 received FDA 510(k) clearance on 2018-03-09, under 510(k) number K180394.

Who is the listed applicant for BrightMatter Plan 1.6.0?

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 Plan 1.6.0?

The FDA product code for BrightMatter Plan 1.6.0 is LLZ.

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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