FDA 510(k) Application Details - K130002

Device Classification Name	More FDA Info for this Device
510(K) Number	K130002
Device Name	SURECALL LABOR MONITOR
Applicant	REPRODUCTIVE RESEARCH TECHNOLOGIES, LP 1770 ST. JAMES, STE 600 HOUSTON, TX 77056-3433 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	01/02/2013
Decision Date	06/28/2013
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