BrainScope TBI (Model: Ahead 400)
K-Number: K183241 · 2019-02-19
ApplicantBrainscope Company, Inc.
Decision Date2019-02-19
Product CodePIW
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
BrainScope TBI (Model: Ahead 400) is a medical device manufactured by Brainscope Company, Inc.. It received FDA 510(k) clearance on 2019-02-19 under approval number K183241. The device is classified under product code PIW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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. It is manufactured by Brainscope Company, Inc.. The 510(k) number is K183241.
When was BrainScope TBI (Model: Ahead 400) approved by the FDA?
BrainScope TBI (Model: Ahead 400) received FDA 510(k) clearance on 2019-02-19, under approval number K183241.
What company makes BrainScope TBI (Model: Ahead 400)?
BrainScope TBI (Model: Ahead 400) is manufactured by Brainscope Company, Inc..
What is the FDA product code for BrainScope TBI (Model: Ahead 400)?
The FDA product code for BrainScope TBI (Model: Ahead 400) is PIW.
Other Devices by Brainscope Company, Inc.
Related Devices (Code: PIW)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.