FDA 510(k) Application Details - K042254

Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone

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510(K) Number K042254
Device Name Transmitters And Receivers, Electrocardiograph, Telephone
Applicant CARD GUARD SCIENTIFIC SURVIVAL, LTD.
2 PERERIS ST., SCIENCE PARK
REHOVOT 76100 IL
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Contact NAAMA OREN
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Regulation Number 870.2920

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Classification Product Code DXH
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Date Received 08/20/2004
Decision Date 01/13/2005
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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