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FDA 510(k) Application Details - K060911
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
More FDA Info for this Device
510(K) Number
K060911
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
2 PEKERIS ST.
REHOVOT 76100 IL
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Contact
ALEX GONOROVSKY
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
04/03/2006
Decision Date
08/22/2006
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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