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FDA 510(k) Application Details - K062137
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
510(K) Number
K062137
Device Name
System, Monitoring, Perinatal
Applicant
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH
HEWLETT-PACKARD STR.2
BOEBLINGEN, BADEN-WTTBG D 71034 DE
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Contact
MARKUS STACHA
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
07/26/2006
Decision Date
08/24/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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