FDA 510(k) Application Details - K973437

Device Classification Name Electrocardiograph

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510(K) Number K973437
Device Name Electrocardiograph
Applicant HEWLETT-PACKARD GMBH
SCHICKARD STRASSE 4
BOEBLINGEN
WUERTTEMBERG 71034 DE
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Contact EGON PFEIL
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Regulation Number 870.2340

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Classification Product Code DPS
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Date Received 09/10/1997
Decision Date 12/03/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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