FDA 510(k) Application Details - K010552

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K010552
Device Name	System, Monitoring, Perinatal
Applicant	CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST. REHOVOT 76100 IL Other 510(k) Applications for this Company
Contact	LEONID TRACHTENBERG 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	02/26/2001
Decision Date	05/11/2001
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