FDA 510(k) Application Details - K072502

Device Classification Name Computer, Diagnostic, Programmable

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510(K) Number K072502
Device Name Computer, Diagnostic, Programmable
Applicant GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
9900 INNAVATION DR.
WAUWATOSA, WI 53226 US
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Contact PATRICIA TAIGE
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Regulation Number 870.1425

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Classification Product Code DQK
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Date Received 09/06/2007
Decision Date 11/19/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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