FDA 510(k) Application Details - K954351

Device Classification Name System, Monitoring, Perinatal

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510(K) Number K954351
Device Name System, Monitoring, Perinatal
Applicant HEWLETT-PACKARD GMBH
SCHICKARD STRASSE 4
BOEBLINGEN
WUERTTEMBERG 71034 DE
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Contact MONICA FERRANTE
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Regulation Number 884.2740

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Classification Product Code HGM
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Date Received 09/18/1995
Decision Date 03/08/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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