FDA 510(k) Application Details - K993751

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K993751
Device Name	System, Monitoring, Perinatal
Applicant	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH WALLINGFORD, CT 06492 US Other 510(k) Applications for this Company
Contact	RICHARD CEHOVSKY 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	11/05/1999
Decision Date	02/02/2000
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