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FDA 510(k) Application Details - K051175
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
884.2740
More FDA Info for this Regulation Number
Classification Product Code
HGM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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