FDA 510(k) Application Details - K031358

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K031358
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	VASCULAR CONTROL SYSTEMS, INC 32236 PASEO ADELANTO, STE. E SAN JUAN CAPISTRANO, CA 92675 US Other 510(k) Applications for this Company
Contact	KATHLEEN ROBERTS Other 510(k) Applications for this Contact
Regulation Number	892.1570   More FDA Info for this Regulation Number
Classification Product Code	ITX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2003
Decision Date	05/09/2003
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	Y
Expedited Review