HRK-123 KNEE ARRAY COIL


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K050299
Device Name HRK-123 KNEE ARRAY COIL
Applicant
MRI DEVICES CORPORATION
n27w23676 paul rd
pewaukee, 
WI 
53072

Applicant Contact tom schubert
Correspondent
MRI DEVICES CORPORATION
n27w23676 paul rd
pewaukee, 
WI 
53072

Correspodent Contact tom schubert
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 02/07/2005
Decision Date 02/24/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No