CERSR ELECTROMYOGRAPHY SYSTEM


Device Classification Name

electromyograph, diagnostic

510(k) Number K110048
Device Name CERSR ELECTROMYOGRAPHY SYSTEM
Applicant
SPINEMATRIX, INC.
1835 market street
29th floor
philadelphia, 
PA 
19103

Applicant Contact janice m hogan
Correspondent
SPINEMATRIX, INC.
1835 market street
29th floor
philadelphia, 
PA 
19103

Correspodent Contact janice m hogan
Regulation Number 890.1375
Classification Product Code
IKN  
Date Received 01/06/2011
Decision Date 01/26/2011
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