BrainScope TBI（型号：Ahead 400）
K号: K183241 · 2019-02-19
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决定日期2019-02-19
产品代码PIW
咨询委员会NE
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决定实质等同
器械摘要
BrainScope TBI (Model: Ahead 400) is the device name listed in this FDA 510(k) record. The listed applicant is Brainscope Company, Inc.. It received FDA 510(k) clearance on 2019-02-19 under 510(k) number K183241. The device is classified under product code PIW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BrainScope TBI (Model: Ahead 400)?
BrainScope TBI (Model: Ahead 400) is a medical device that received FDA 510(k) clearance on 2019-02-19. The listed applicant is Brainscope Company, Inc.. The 510(k) number is K183241.
When did BrainScope TBI (Model: Ahead 400) receive FDA 510(k) clearance?
BrainScope TBI (Model: Ahead 400) received FDA 510(k) clearance on 2019-02-19, under 510(k) number K183241.
Who is the listed applicant for BrainScope TBI (Model: Ahead 400)?
The FDA 510(k) record lists Brainscope Company, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BrainScope TBI (Model: Ahead 400)?
The FDA product code for BrainScope TBI (Model: Ahead 400) is PIW.
相关临床试验
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列明Brainscope Company, 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。
相关器械（代码：PIW）
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。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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