FDA 510(k) Application Details - K960553

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K960553
Device Name	System, Monitoring, Perinatal
Applicant	CARD GUARD SCIENTIFIC SURVIVAL, LTD. 3649 SEHORN DR. MALIBU, CA 90265 US Other 510(k) Applications for this Company
Contact	ANNE LAURITZEN 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	02/08/1996
Decision Date	04/22/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review