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FDA 510(k) Application Details - K013389
Device Classification Name
Index-Generating Electroencephalograph Software
More FDA Info for this Device
510(K) Number
K013389
Device Name
Index-Generating Electroencephalograph Software
Applicant
DATEX-OHMEDA
86 PILGRIM RD.
NEEDHAM, MA 02492 US
Other 510(k) Applications for this Company
Contact
JOEL KENT
Other 510(k) Applications for this Contact
Regulation Number
882.1400
More FDA Info for this Regulation Number
Classification Product Code
OLW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/12/2001
Decision Date
01/10/2002
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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