FDA 510(k) Application Details - K963711

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K963711
Device Name	System, Monitoring, Perinatal
Applicant	HUNTLEIGH HEALTHCARE, INC. 227 RT. 33 EAST MANALAPAN, NJ 07726 US Other 510(k) Applications for this Company
Contact	AUDREY WITKO 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	09/16/1996
Decision Date	09/12/1997
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