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FDA 510(k) Application Details - K970659
Device Classification Name
Encephalogram Telemetry System
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510(K) Number
K970659
Device Name
Encephalogram Telemetry System
Applicant
TELEDIAGNOSTIC SYSTEMS, INC.
2053 SUTTER ST.
SAN FRANCISCO, CA 94115 US
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Contact
LARRY WOODARD
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Regulation Number
882.1855
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Classification Product Code
GYE
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More FDA Info for this Product Code
Date Received
02/21/1997
Decision Date
05/16/1997
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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