FMRI HARDWARE SYSTEM


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K073099
Device Name FMRI HARDWARE SYSTEM
Applicant
NORDICNEUROLAB
6470 riverview terrace ne
minneapolis, 
MN 
55432

Applicant Contact constance g bundy
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 11/02/2007
Decision Date 11/20/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No