EMG SYSTEM


Device Classification Name

device, biofeedback

510(k) Number K111687
Device Name EMG SYSTEM
Applicant
MYOTRONICS-NOROMED, INC.
5870 s. 194th st.
kent, 
WA 
98032 -2126

Applicant Contact f. adib
Correspondent
MYOTRONICS-NOROMED, INC.
5870 s. 194th st.
kent, 
WA 
98032 -2126

Correspodent Contact f. adib
Regulation Number 882.5050
Classification Product Code
HCC  
Date Received 06/16/2011
Decision Date 09/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Ear Nose & Throat

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No