FDA 510(k) Application Details - K111083

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K111083
Device Name	System, Monitoring, Perinatal
Applicant	PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 BOEBLINGEN 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	04/19/2011
Decision Date	08/17/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review