FDA 510(k) Application Details - K974087

Device Classification Name System, Ecg Analysis

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510(K) Number K974087
Device Name System, Ecg Analysis
Applicant HEWLETT-PACKARD CO.
3000 MINUTEMAN RD.
ANDOVER, MA 01810-1085 US
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Contact RAY STELTING
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Regulation Number 000.0000

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Classification Product Code LOS
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Date Received 10/29/1997
Decision Date 06/15/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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