ARTEMIS


Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K021333
Device Name ARTEMIS
Original Applicant
ULTRALINK, LLC.
2083 hawaii ave n.e.
st petersburg, 
FL 
33707

Original Contact george d wiseman
Regulation Number 892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received 04/26/2002
Decision Date 10/08/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No