FDA 510(k) Application Details - K000034

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K000034
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	OPTIMAL IMAGING SYSTEMS, INC. 9344 NW 13TH ST. SUITE 200 MIAMI, FL 33172 US Other 510(k) Applications for this Company
Contact	JORGE MILLIAN 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	01/06/2000
Decision Date	02/24/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review