FDA 510(k) Application Details - K112390

Device Classification Name	More FDA Info for this Device
510(K) Number	K112390
Device Name	MONICA AN24
Applicant	MONICA HEALTHCARE LTD. BIOCITY, PENNYFOOT STREET NOTTINGHAM NG1 1GF GB Other 510(k) Applications for this Company
Contact	IAN HOW 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	08/18/2011
Decision Date	07/13/2012
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