HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K111340
Device Name HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM
Applicant
MEDTEC, INC.
1401 8th street se
orange city, 
IA 
51041

Applicant Contact jenny jones
Correspondent
MEDTEC, INC.
1401 8th street se
orange city, 
IA 
51041

Correspodent Contact jenny jones
Regulation Number 892.1000
Classification Product Code
LNH  
Subsequent Product Code
IYE  
Date Received 05/12/2011
Decision Date 06/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No