3.0T METAFLEXCOIL


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K103342
Device Name 3.0T METAFLEXCOIL
Applicant
NEOCOIL, LLC
n27 w23910a paul rd.
pewaukee, 
WI 
53072

Applicant Contact brian brown
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 11/15/2010
Decision Date 12/23/2010
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party Yes

Combination Product

No