FDA 510(k) Application Details - K060410

Device Classification Name	Monitor, Heart Sound, Fetal, Ultrasonic   More FDA Info for this Device
510(K) Number	K060410
Device Name	Monitor, Heart Sound, Fetal, Ultrasonic
Applicant	SUMMIT DOPPLER SYSTEMS, INC. 4620 TECHNOLOGY DR. UNIT 100 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	HEK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/16/2006
Decision Date	04/10/2006
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