SUPERNOVA DIAGNOSTIC ULTRASOUND SCANNING SYSTEM


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K022858
Device Name SUPERNOVA DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
Original Applicant
NOVASONICS, INC.
1061 terra bella ave.
mountain vies, 
CA 
94043

Original Contact cheryl a blake
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 08/28/2002
Decision Date 09/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No