Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K082886
Device Classification Name
Non-Normalizing Quantitative Electroencephalograph Software
More FDA Info for this Device
510(K) Number
K082886
Device Name
Non-Normalizing Quantitative Electroencephalograph Software
Applicant
BRAINSCOPE COMPANY, INC.
1717 RHODE ISLAND AVE.
9TH FLOOR
WASHINGTON, DC 20036 US
Other 510(k) Applications for this Company
Contact
MICHAEL E SINGER
Other 510(k) Applications for this Contact
Regulation Number
882.1400
More FDA Info for this Regulation Number
Classification Product Code
OLT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/30/2008
Decision Date
08/10/2009
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact