FDA 510(k) Application Details - K032577

Device Classification Name Computer, Diagnostic, Programmable

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510(K) Number K032577
Device Name Computer, Diagnostic, Programmable
Applicant GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 WEST TOWER AVE.
MILWAUKEE, WI 53223 US
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Contact LISA L MICHELS
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Regulation Number 870.1425

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Classification Product Code DQK
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Date Received 08/21/2003
Decision Date 10/10/2003
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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