FDA 510(k) Application Details - K121208

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K121208
Device Name	System, Monitoring, Perinatal
Applicant	CLINICAL COMPUTER SYSTEMS, INC. 715 TOLLGATE RD. UNIT H ELGIN, IL 60123-9331 US Other 510(k) Applications for this Company
Contact	CYNTHIA BELL 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	04/20/2012
Decision Date	06/14/2012
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	Y
Expedited Review