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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Brainscope Company, Inc.. It received FDA 510(k) clearance on 2019-02-19 under 510(k) 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. The listed applicant is Brainscope Company, Inc.. The 510(k) number is K183241.

When did BrainScope TBI (Model: Ahead 400) receive FDA 510(k) clearance?

BrainScope TBI (Model: Ahead 400) received FDA 510(k) clearance on 2019-02-19, under 510(k) number K183241.

Who is the listed applicant for BrainScope TBI (Model: Ahead 400)?

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 TBI (Model: Ahead 400)?

The FDA product code for BrainScope TBI (Model: Ahead 400) 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 TBIK181785Modified BrainScope OneK181179BrainScope 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.K181785Modified BrainScope OneBrainscope Company, Inc.K181179BrainScope 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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