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BrainScope Ahead 100

DEN140025 Class II Direct
Decision Date
2014-11-17
Sponsor / Applicant
Brainscope Company, Inc.

Technical Specification

510(k) Submission ID DEN140025
Product Code PIW
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.1450
Decision Date 2014-11-17
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

BrainScope Ahead 100 received FDA 510(k) clearance under submission number DEN140025, sponsored by Brainscope Company, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2014-11-17.

Classification & Regulation

This clearance is catalogued under FDA product code PIW and 21 CFR 882.1450, within the Neurology review panel as a Class II device.