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FDA 510(k) Application Details - K113514
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
More FDA Info for this Device
510(K) Number
K113514
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
SHL TELEMEDICINE INTERNATIONAL LTD.
31 HAAVODA ST.
BINYAMINA 30500 IL
Other 510(k) Applications for this Company
Contact
YORAM LEVY
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
11/28/2011
Decision Date
02/22/2012
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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