FDA 510(k)

BrainScope TBI

K-Number: K190815 · 2019-09-11

Decision Date2019-09-11

Product CodePIW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

BrainScope TBI 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 2019-09-11 under 510(k) 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. The listed applicant is Brainscope Company, Inc.. The 510(k) number is K190815.

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

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

Who is the listed applicant for BrainScope TBI?

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?

The FDA product code for BrainScope TBI 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.

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

Related Devices (Code: PIW)

K243426Nurochek-Pro SystemHeadsafe Mfg Pty, Ltd.K231914Nurochek-II SystemHeadsafe Mfg Pty, Ltd.K183241BrainScope TBI (Model: Ahead 400)Brainscope 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.