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FDA 510(k) Application Details - K023380
Device Classification Name
Computer, Diagnostic, Programmable
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510(K) Number
K023380
Device Name
Computer, Diagnostic, Programmable
Applicant
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
8200 WEST TOWER AVE.
MILWAUKEE, WI 53223 US
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Contact
DAVID WAHLIG
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Regulation Number
870.1425
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Classification Product Code
DQK
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More FDA Info for this Product Code
Date Received
10/08/2002
Decision Date
12/03/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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