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FDA 510(k) Application Details - K082421
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K082421
Device Name
Computer, Diagnostic, Programmable
Applicant
EMAGEON INC.
900 WALNUT RIDGE DRIVE
HARTLAND, WI 53029 US
Other 510(k) Applications for this Company
Regulation Number
870.1425
More FDA Info for this Regulation Number
Classification Product Code
DQK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/22/2008
Decision Date
12/17/2008
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
Y
Expedited Review
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