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FDA 510(k) Application Details - K063609
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
More FDA Info for this Device
510(K) Number
K063609
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
SHL TELEMEDICINE INTERNATIONAL LTD.
291 HILLSIDE AVE.
SOMERSET, MA 02726 US
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Contact
GEORGE J HATTUB
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
12/04/2006
Decision Date
09/12/2007
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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