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FDA 510(k)

Modified BrainScope One

K-Number: K181785 · 2018-12-19

ApplicantBrainscope Company, Inc.
Decision Date2018-12-19
Product CodePIW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Modified BrainScope One is a medical device manufactured by Brainscope Company, Inc.. It received FDA 510(k) clearance on 2018-12-19 under approval number K181785. 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 Modified BrainScope One?

Modified BrainScope One is a medical device that received FDA 510(k) clearance on 2018-12-19. It is manufactured by Brainscope Company, Inc.. The 510(k) number is K181785.

When was Modified BrainScope One approved by the FDA?

Modified BrainScope One received FDA 510(k) clearance on 2018-12-19, under approval number K181785.

What company makes Modified BrainScope One?

Modified BrainScope One is manufactured by Brainscope Company, Inc..

What is the FDA product code for Modified BrainScope One?

The FDA product code for Modified BrainScope One is PIW.

Other Devices by Brainscope Company, Inc.

K161068Ahead 300 K181179BrainScope One K190815BrainScope TBI K183241BrainScope TBI (Model: Ahead 400)

Related Devices (Code: PIW)

K161068Ahead 300Brainscope Company, Inc. K181179BrainScope OneBrainscope Company, Inc. K190815BrainScope TBIBrainscope Company, Inc. K183241BrainScope TBI (Model: Ahead 400)Brainscope Company, Inc. K231914Nurochek-II SystemHeadsafe Mfg Pty, Ltd. K243426Nurochek-Pro SystemHeadsafe Mfg Pty, Ltd.

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.

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