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FDA 510(k) Application Details - K151245
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K151245
Device Name
Computer, Diagnostic, Programmable
Applicant
TOPERA, INC.
1530 OBRIEN DR., SUITE A
MENLO PARK, CA 94025 US
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Contact
Dennis Pozzo
Other 510(k) Applications for this Contact
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
05/11/2015
Decision Date
09/15/2015
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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