SMARTTROAE


Device Classification Name

audiometer

510(k) Number K023859
Device Name SMARTTROAE
Original Applicant
INTELLIGENT HEARING SYSTEMS
7356 s.w. 48 st.
miami, 
FL 
33155

Original Contact edward miskiel
Regulation Number 874.1050
Classification Product Code
EWO  
Date Received 11/20/2002
Decision Date 01/08/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No