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FDA 510(k) Application Details - K061428
Device Classification Name
System,Network And Communication,Physiological Monitors
More FDA Info for this Device
510(K) Number
K061428
Device Name
System,Network And Communication,Physiological Monitors
Applicant
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
2 PEKERIS ST., SCIENCE PARK
P.O.B. 527
REHOVOT 76100 IL
Other 510(k) Applications for this Company
Contact
ALEX GONOROVSKY
Other 510(k) Applications for this Contact
Regulation Number
870.2300
More FDA Info for this Regulation Number
Classification Product Code
MSX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/23/2006
Decision Date
10/16/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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