FYRELINK


Device Classification Name

system, image processing, radiological

510(k) Number K030242
Device Name FYRELINK
Original Applicant
MPACS, LLC.
7601 ganser way
madison, 
WI 
53719

Original Contact greg sopotnick
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 01/23/2003
Decision Date 03/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No