FDA 510(k) Application Details - K003141

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K003141
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	PARADIGM MEDICAL INDUSTRIES, INC. 2355 SOUTH 1070 WEST SALT LAKE CITY, UT 84119 US Other 510(k) Applications for this Company
Contact	TRACY S BEST Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	IYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/10/2000
Decision Date	12/05/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review