FDA 510(k) Application Details - K061428

Device Classification Name System,Network And Communication,Physiological Monitors

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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
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Contact ALEX GONOROVSKY
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Regulation Number 870.2300

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Classification Product Code MSX
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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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