FDA 510(k) Application Details - K002150

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K002150
Device Name	System, Monitoring, Perinatal
Applicant	OXFORD INSTRUMENTS MANOR WAY OLD WOKING, SURREY GU22 9JU GB Other 510(k) Applications for this Company
Contact	STEVE VALE 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	07/17/2000
Decision Date	03/09/2001
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