FDA 510(k) Application Details - K090285

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K090285
Device Name	System, Monitoring, Perinatal
Applicant	HUNTLEIGH HEALTHCARE LTD. 35 PORTMANMOOR RD. CARDIFF, SOUTH WALES CF24 5HN GB Other 510(k) Applications for this Company
Contact	GRAHAM BOOTH 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	02/05/2009
Decision Date	07/15/2009
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