FDA 510(k) Application Details - K043597

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K043597
Device Name	System, Monitoring, Perinatal
Applicant	BIONET CO., LTD. MEDICAL INDUSTRY TECHNO TOWER R205, 1272 MAEJI HEUNGUP WONJU, KWANGWON-DO KR Other 510(k) Applications for this Company
Contact	SUN-YOUNG JEONG 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	12/29/2004
Decision Date	12/16/2005
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