FDA 510(k) Application Details - K973562

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K973562
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. GOLDEN, CO 80403 US Other 510(k) Applications for this Company
Contact	DAVID W WAGNER Other 510(k) Applications for this Contact
Regulation Number	892.1550   More FDA Info for this Regulation Number
Classification Product Code	IYN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/19/1997
Decision Date	04/15/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review