FDA 510(k) Application Details - K072976

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K072976
Device Name	System, Monitoring, Perinatal
Applicant	GE HEALTHCARE 8880 GORMAN RD LAUREL, MD 20723 US Other 510(k) Applications for this Company
Contact	AGATA SMIEJA 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	10/25/2007
Decision Date	12/20/2007
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