FDA 510(k) Application Details - K100885

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K100885
Device Name	System, Monitoring, Perinatal
Applicant	BISTOS CO., LTD. 111 ELLISON STREET PATERSON, NJ 07505 US Other 510(k) Applications for this Company
Contact	YOUNG CHI 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	03/30/2010
Decision Date	06/07/2010
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