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FDA 510(k) Application Details - K143643
Device Classification Name
More FDA Info for this Device
510(K) Number
K143643
Device Name
Brainscope Ahead 200
Applicant
BRAINSCOPE COMPANY, INC.
4350 EAST-WEST HIGHWAY
SUITE 1050
BETHESDA, MD 20814 US
Other 510(k) Applications for this Company
Contact
Michael E Singer
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PIW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/22/2014
Decision Date
05/15/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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