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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 the device name listed in this FDA 510(k) record. The listed applicant is Brainscope Company, Inc.. It received FDA 510(k) clearance on 2018-05-18 under 510(k) 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. The listed applicant is Brainscope Company, Inc.. The 510(k) number is K181179.

When did BrainScope One receive FDA 510(k) clearance?

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

Who is the listed applicant for BrainScope One?

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 One?

The FDA product code for BrainScope One is PIW.

Other records listing Brainscope Company, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190815BrainScope TBIK183241BrainScope TBI (Model: Ahead 400)K181785Modified BrainScope OneK161068Ahead 300

Related Devices (Code: PIW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243426Nurochek-Pro SystemHeadsafe Mfg Pty, Ltd.K231914Nurochek-II SystemHeadsafe Mfg Pty, Ltd.K190815BrainScope TBIBrainscope Company, Inc.K183241BrainScope TBI (Model: Ahead 400)Brainscope Company, Inc.K181785Modified BrainScope OneBrainscope Company, Inc.K161068Ahead 300Brainscope Company, Inc.

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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