FDA 510(k) Application Details - K993616

Device Classification Name System, Ecg Analysis

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510(K) Number K993616
Device Name System, Ecg Analysis
Applicant NASIFF ASSOC., INC.
9422 LEBEAU LN.
BREWERTON, NY 13029 US
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Contact ROGER E NASIFF
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Regulation Number 000.0000

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Classification Product Code LOS
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Date Received 10/26/1999
Decision Date 04/10/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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