MODEL 6600GE-64: TRAMA NECK ARRAY


the company

Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K002864
Device Name MODEL 6600GE-64: TRAMA NECK ARRAY
Original Applicant
MIDWEST R.F. LLC.
535 norton dr.
hartland, 
WI 
53029

Original Contact ralph s hashoian
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 09/13/2000
Decision Date 11/21/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized