FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058


Device Classification Name

electrode, cutaneous

510(k) Number K080902
Device Name FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058
Applicant
LORENZ BIOTECH S.P.A.
49 plain street
north attleboro, 
MA 
02760

Applicant Contact rosina robinson
Correspondent
LORENZ BIOTECH S.P.A.
49 plain street
north attleboro, 
MA 
02760

Correspodent Contact rosina robinson
Regulation Number 882.1320
Classification Product Code
GXY  
Date Received 04/02/2008
Decision Date 06/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No