FDA 510(k) Application Details - K963811

Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone

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510(K) Number K963811
Device Name Transmitters And Receivers, Electrocardiograph, Telephone
Applicant CARD GUARD SCIENTIFIC SURVIVAL, LTD.
6156 EAST GREENWAY LN.
SCOTTSDALE, AZ 85254 US
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Contact BOAZ VINOGRADOV
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Regulation Number 870.2920

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Classification Product Code DXH
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Date Received 09/23/1996
Decision Date 12/04/1996
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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