FDA 510(k) Application Details - K051175

Device Classification Name System, Monitoring, Perinatal

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510(K) Number K051175
Device Name System, Monitoring, Perinatal
Applicant CIVENT COMMUNICATIONS LTD
MESHEK 58
BEN NNATAN
MOSHAV HEMED 50295 IL
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Contact RUDI LOKITS
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Regulation Number 884.2740

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Classification Product Code HGM
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Date Received 05/06/2005
Decision Date 02/17/2006
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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