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FDA 510(k) Application Details - K081203
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
510(K) Number
K081203
Device Name
System, Monitoring, Perinatal
Applicant
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
HEWLETT-PACKARD STR. 2
BOEBLINGEN
BADEN-WUERTTEMBERG D-71034 DE
Other 510(k) Applications for this Company
Contact
MICHAEL ASMALSKY
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
04/28/2008
Decision Date
05/28/2008
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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