EMG RECORDING RING ELECTRODE


Device Classification Name

electrode, cutaneous

510(k) Number K953356
Device Name EMG RECORDING RING ELECTRODE
Applicant
CHALGREN ENTERPRISES, INC.
8021 carmel st.
suite b
gilroy, 
CA 
95020

Applicant Contact richard kaiser
Correspondent
CHALGREN ENTERPRISES, INC.
8021 carmel st.
suite b
gilroy, 
CA 
95020

Correspodent Contact richard kaiser
Regulation Number 882.1320
Classification Product Code
GXY  
Date Received 07/17/1995
Decision Date 01/22/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

Type Traditional
Reviewed by Third Party No

Combination Product

No