FDA 510(k) Application Details - K052795

Device Classification Name System, Monitoring, Perinatal

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510(K) Number K052795
Device Name System, Monitoring, Perinatal
Applicant PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH
HEWLETT-PACKARD STR.2
BOEBLINGEN D 71034 DE
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Contact MARKUS STACHA
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Regulation Number 884.2740

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Classification Product Code HGM
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Date Received 10/03/2005
Decision Date 12/30/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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