MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K011608
Device Name MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL
Original Applicant
MEDICAL ADVANCES, INC.
10437 innovation dr.
milwaukee, 
WI 
53226

Original Contact michael j leigh
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 05/25/2001
Decision Date 08/14/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No