FDA 510(k) Application Details - K032225

Device Classification Name Computer, Diagnostic, Programmable

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510(K) Number K032225
Device Name Computer, Diagnostic, Programmable
Applicant EP MEDSYSTEMS
COOPER RUN EXECUTIVE PARK
575 ROUTE 73 N. BLDG. D
WEST BERLIN, NJ 08091 US
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Contact JAMES E KUHN
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Regulation Number 870.1425

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Classification Product Code DQK
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Date Received 07/21/2003
Decision Date 08/20/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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