INTUITION, MODEL 0170


Device Classification Name

system, x-ray, stationary

510(k) Number K073632
Device Name INTUITION, MODEL 0170
Applicant
ARCOMA AB
annavagen 1
vaxjo, 

SE

s-352 46

Applicant Contact bengt-hugo johansson
Regulation Number 892.1680
Classification Product Code
KPR  
Date Received 12/26/2007
Decision Date 01/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No