TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES


Device Classification Name

electrode, needle, diagnostic electromyograph

510(k) Number K111131
Device Name TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES
Applicant
CAREFUSION 209, INC.
1850 deming way
middleton, 
WI 
53562

Applicant Contact glen hermanson
Correspondent
CAREFUSION 209, INC.
1850 deming way
middleton, 
WI 
53562

Correspodent Contact glen hermanson
Regulation Number 890.1385
Classification Product Code
IKT  
Subsequent Product Code
GXZ  
Date Received 04/21/2011
Decision Date 06/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No