FDA 510(k) Application Details - K030261

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K030261
Device Name	System, Monitoring, Perinatal
Applicant	ACCESS BATTERY, INC. 5357 HIGHWAY 86 ELIZABETH, CO 80107 US Other 510(k) Applications for this Company
Contact	ALEXANDER B HENDERSON 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	01/24/2003
Decision Date	04/24/2003
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