FDA 510(k) Application Details - K990478

Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone

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510(K) Number K990478
Device Name Transmitters And Receivers, Electrocardiograph, Telephone
Applicant CARD GUARD SCIENTIFIC SURVIVAL, LTD.
2 PEKERIS ST.
REHOVOT 76100 IL
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Contact LEONID TRACHTENBERG
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Regulation Number 870.2920

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Classification Product Code DXH
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Date Received 02/16/1999
Decision Date 08/31/1999
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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