FDA 510(k) Application Details - K043075

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K043075
Device Name	System, Monitoring, Perinatal
Applicant	TENACORE HOLDINGS, INC. 647 EAST YOUNG STREET SANTA ANA, CA 92705 US Other 510(k) Applications for this Company
Contact	Brand Caso 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	11/08/2004
Decision Date	08/18/2005
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