FDA 510(k) Application Details - K090145

Device Classification Name	More FDA Info for this Device
510(K) Number	K090145
Device Name	SURECALL EMG LABOR MONITOR
Applicant	REPRODUCTIVE RESEARCH TECHNOLOGIES, LP 11874 SOUTH EVELYN HOUSTON, TX 77071 US Other 510(k) Applications for this Company
Contact	J. HARVEY KNAUSS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OSP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/21/2009
Decision Date	01/25/2011
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