FDA 510(k) Application Details - K110612

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K110612
Device Name	System, Monitoring, Perinatal
Applicant	MEDIANA CO., LTD. WONJU MEDICAL IND. PARK 1650-1 DONGHWA-RI, MUNMAK-EUP WONJU-SI, GANGWON-DO 220-801 KR Other 510(k) Applications for this Company
Contact	AMY KIM 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	03/03/2011
Decision Date	11/08/2011
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	Y
Expedited Review