TEM 3002G- HN DUAL TUNE HEAD COIL


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K080820
Device Name TEM 3002G- HN DUAL TUNE HEAD COIL
Applicant
MR INSTRUMENTS, INC.
5610 rowland road
suite 145
minnetonka, 
MN 
55343

Applicant Contact mark watson
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 03/24/2008
Decision Date 04/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No