FDA 510(k) Application Details - K131889

Device Classification Name	More FDA Info for this Device
510(K) Number	K131889
Device Name	EUM 100PRO
Applicant	PROMEDIC, INC. 24301 WOODSAGE DR BONITA SPRINGS, FL 34134-2958 US Other 510(k) Applications for this Company
Contact	PAUL DRYDEN 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	06/25/2013
Decision Date	04/23/2014
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