FDA 510(k) Application Details - K963195

Device Classification Name	Encephalogram Telemetry System   More FDA Info for this Device
510(K) Number	K963195
Device Name	Encephalogram Telemetry System
Applicant	CME TELEMETRIX, INC. 1129 BLOOMFIELD AVE. WEST CALDWELL, NJ 07006 US Other 510(k) Applications for this Company
Contact	ANNE MARIE CESARIO Other 510(k) Applications for this Contact
Regulation Number	882.1855   More FDA Info for this Regulation Number
Classification Product Code	GYE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/1996
Decision Date	07/29/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review