MODEL 1300GE-64: PEDIATRIC POSITIONER


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K030317
Device Name MODEL 1300GE-64: PEDIATRIC POSITIONER
Original Applicant
MIDWEST R.F. LLC.
535 norton dr.
hartland, 
WI 
53029

Original Contact helmut keidl
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 01/30/2003
Decision Date 03/25/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No