FDA 510(k) Application Details - K030466

Device Classification Name	Monitor, Ultrasonic, Fetal   More FDA Info for this Device
510(K) Number	K030466
Device Name	Monitor, Ultrasonic, Fetal
Applicant	ELCAT, GMBH 1308 MORNINGSIDE PARK DR. ALPHARETTA, GA 30022 US Other 510(k) Applications for this Company
Contact	JAY MANSOUR 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	02/12/2003
Decision Date	09/12/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review