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FDA 510(k) Application Details - K023931
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
510(K) Number
K023931
Device Name
System, Monitoring, Perinatal
Applicant
PHILIPS MEDICAL SYSTEMS, INC.
NEDERLAND B.V.
POSTBUS 10.000
DA BEST 5680 NL
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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
11/26/2002
Decision Date
02/24/2003
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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