FDA 510(k) Application Details - K061091

Device Classification Name	Monitor, Ultrasonic, Fetal   More FDA Info for this Device
510(K) Number	K061091
Device Name	Monitor, Ultrasonic, Fetal
Applicant	THE NEWMAN GROUP, LLC 935 WEST CHESTNUT ST. SUITE 430 CHICAGO, IL 60622 US Other 510(k) Applications for this Company
Contact	SPENCER NEWMAN Other 510(k) Applications for this Contact
Regulation Number	884.2660   More FDA Info for this Regulation Number
Classification Product Code	KNG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/2006
Decision Date	05/04/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review