BE PLUS LTM AMPLIFIER GWI AMPLIFIER


Device Classification Name

amplifier, physiological signal

510(k) Number K121996
Device Name BE PLUS LTM AMPLIFIER GWI AMPLIFIER
Applicant
EB NEURO, S.P.A.
9001 wesleyan road
indianapolis, 
IN 
46268

Applicant Contact allison scott
Correspondent
EB NEURO, S.P.A.
9001 wesleyan road
indianapolis, 
IN 
46268

Correspodent Contact allison scott
Regulation Number 882.1835
Classification Product Code
GWL  
Date Received 07/09/2012
Decision Date 08/03/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No