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FDA 510(k) Application Details - K082077
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
More FDA Info for this Device
510(K) Number
K082077
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
CORSCIENCE GMBH & CO. KG
700-706 SECO RD
MONROEVILLE, PA 15146 US
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Contact
PATRIK KAREM
Other 510(k) Applications for this Contact
Regulation Number
870.2920
More FDA Info for this Regulation Number
Classification Product Code
DXH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/23/2008
Decision Date
09/02/2008
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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