FDA 510(k) Application Details - K031550

Device Classification Name Computer, Diagnostic, Programmable

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510(K) Number K031550
Device Name Computer, Diagnostic, Programmable
Applicant VIVOMETRICS, INC.
555 THIRTEENTH ST. NW
WASHINGTON, DC 20004-1109 US
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Contact HOWARD M HOLSTEIN
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Regulation Number 870.1425

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Classification Product Code DQK
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Date Received 05/16/2003
Decision Date 07/29/2003
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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