FDA 510(k) Application Details - K955015

Device Classification Name Computer, Diagnostic, Programmable

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510(K) Number K955015
Device Name Computer, Diagnostic, Programmable
Applicant ZYMED MEDICAL INSTRUMENTATION
20 NORTH AVIADOR ST.
CAMARILLO, CA 93010 US
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Contact JOHN DUDLEY HARRIS
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Regulation Number 870.1425

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Classification Product Code DQK
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Date Received 11/01/1995
Decision Date 03/18/1996
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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