FDA 510(k) Application Details - K090499

Device Classification Name	Monitor, Fetal Doppler Ultrasound   More FDA Info for this Device
510(K) Number	K090499
Device Name	Monitor, Fetal Doppler Ultrasound
Applicant	SUMMIT DOPPLER SYSTEMS, INC. 4680 TABLE MOUNTAIN DR #150 GOLDEN, CO 80403 US Other 510(k) Applications for this Company
Contact	KEN JARRELL Other 510(k) Applications for this Contact
Regulation Number	884.2660   More FDA Info for this Regulation Number
Classification Product Code	MAA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/25/2009
Decision Date	03/31/2009
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	Y
Expedited Review