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FDA 510(k)

BrainScope TBI

K-Number: K190815 · 2019-09-11

ApplicantBrainscope Company, Inc.
Decision Date2019-09-11
Product CodePIW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BrainScope TBI is a medical device manufactured by Brainscope Company, Inc.. It received FDA 510(k) clearance on 2019-09-11 under approval number K190815. 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?

BrainScope TBI is a medical device that received FDA 510(k) clearance on 2019-09-11. It is manufactured by Brainscope Company, Inc.. The 510(k) number is K190815.

When was BrainScope TBI approved by the FDA?

BrainScope TBI received FDA 510(k) clearance on 2019-09-11, under approval number K190815.

What company makes BrainScope TBI?

BrainScope TBI is manufactured by Brainscope Company, Inc..

What is the FDA product code for BrainScope TBI?

The FDA product code for BrainScope TBI is PIW.

Other Devices by Brainscope Company, Inc.

K161068Ahead 300 K181785Modified BrainScope One K181179BrainScope One K183241BrainScope TBI (Model: Ahead 400)

Related Devices (Code: PIW)

K161068Ahead 300Brainscope Company, Inc. K181785Modified BrainScope OneBrainscope Company, Inc. K181179BrainScope OneBrainscope Company, Inc. K183241BrainScope TBI (Model: Ahead 400)Brainscope Company, Inc. K231914Nurochek-II SystemHeadsafe Mfg Pty, Ltd. K243426Nurochek-Pro SystemHeadsafe Mfg Pty, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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