FDA 510(k) Application Details - K112187

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K112187
Device Name	System, Monitoring, Perinatal
Applicant	ADVANCED INSTRUMENTATIONS, INC. 601 W 20 ST HIALEAH, FL 33010 US Other 510(k) Applications for this Company
Contact	JORGE MILLAN 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	07/29/2011
Decision Date	09/21/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review