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FDA 510(k) Application Details - K021495
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K021495
Device Name
Computer, Diagnostic, Programmable
Applicant
PIE MEDICAL IMAGING B.V.
7992 CASTLEWAY DR.
INDIANAPOLIS, IN 46250 US
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Contact
COLLEEN DENSMORE
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Regulation Number
870.1425
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Classification Product Code
DQK
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More FDA Info for this Product Code
Date Received
05/09/2002
Decision Date
10/01/2002
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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