SV DBS VRAIN ARRAY


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K111259
Device Name SV DBS VRAIN ARRAY
Applicant
MIDWEST RF, LLC
p.o. box 348
1015 walnut ridge drive
hartland, 
WI 
53029

Applicant Contact helmut keidi
Correspondent
MIDWEST RF, LLC
p.o. box 348
1015 walnut ridge drive
hartland, 
WI 
53029

Correspodent Contact helmut keidi
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 05/04/2011
Decision Date 07/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No