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FDA 510(k) Application Details - K955015
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.1425
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Classification Product Code
DQK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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