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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
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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
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