MRJ EXTENDED


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K080098
Device Name MRJ EXTENDED
Applicant
PARAMED SRL
39 high street
north andover, 
MA 
01845

Applicant Contact michael a douglas
Correspondent
PARAMED SRL
39 high street
north andover, 
MA 
01845

Correspodent Contact michael a douglas
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 01/14/2008
Decision Date 03/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No