SMART COUPLER, MODEL M015401


Device Classification Name

stimulator, auditory, evoked response

510(k) Number K073384
Device Name SMART COUPLER, MODEL M015401
Applicant
INTELLIGENT HEARING SYSTEMS
6860 s.w. 81st st.
miami, 
FL 
33143

Applicant Contact edward miskiel
Correspondent
INTELLIGENT HEARING SYSTEMS
6860 s.w. 81st st.
miami, 
FL 
33143

Correspodent Contact edward miskiel
Regulation Number 882.1900
Classification Product Code
GWJ  
Date Received 12/03/2007
Decision Date 02/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No