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FDA 510(k) Application Details - K123295
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K123295
Device Name
Computer, Diagnostic, Programmable
Applicant
TOPERA, INC.
1324 CLARKSON CLAYTON CENTER, #332
BALLWIN, MO 63011 US
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Contact
MELISSA WALKER
Other 510(k) Applications for this Contact
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
10/22/2012
Decision Date
04/24/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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