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FDA 510(k)

BrainScope One

K-Number: K181179 · 2018-05-18

ApplicantBrainscope Company, Inc.
Decision Date2018-05-18
Product CodePIW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BrainScope One is a medical device manufactured by Brainscope Company, Inc.. It received FDA 510(k) clearance on 2018-05-18 under approval number K181179. 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 One?

BrainScope One is a medical device that received FDA 510(k) clearance on 2018-05-18. It is manufactured by Brainscope Company, Inc.. The 510(k) number is K181179.

When was BrainScope One approved by the FDA?

BrainScope One received FDA 510(k) clearance on 2018-05-18, under approval number K181179.

What company makes BrainScope One?

BrainScope One is manufactured by Brainscope Company, Inc..

What is the FDA product code for BrainScope One?

The FDA product code for BrainScope One is PIW.

Other Devices by Brainscope Company, Inc.

K161068Ahead 300 K181785Modified BrainScope One K190815BrainScope TBI K183241BrainScope TBI (Model: Ahead 400)

Related Devices (Code: PIW)

K161068Ahead 300Brainscope Company, Inc. K181785Modified BrainScope 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

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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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