FDA 510(k) Application Details - K960499

Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone

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510(K) Number K960499
Device Name Transmitters And Receivers, Electrocardiograph, Telephone
Applicant UNIVERSAL MEDICAL, INC.
1760 MARKET ST.
13TH FLOOR
PHILADELPHIA, PA 19103 US
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Contact MARGARET S LURIO
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Regulation Number 870.2920

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Classification Product Code DXH
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Date Received 02/02/1996
Decision Date 08/06/1996
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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