1.5T 16CH FLEX SPEEDER LARGE


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K121362
Device Name 1.5T 16CH FLEX SPEEDER LARGE
Applicant
NEOCOIL, LLC
n27 w23910a paul rd.
pewaukee, 
WI 
53072

Applicant Contact steven nichols
Correspondent
NEOCOIL, LLC
n27 w23910a paul rd.
pewaukee, 
WI 
53072

Correspodent Contact steven nichols
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 05/07/2012
Decision Date 06/15/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No