Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - DEN140025
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN140025
Device Name
BrainScope Ahead 100
Applicant
BRAINSCOPE COMPANY, INC
4350 EAST-WEST HWY
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
08/20/2014
Decision Date
11/17/2014
Decision
DENG -
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
Y
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact