AUDIOSCREENER OAE+ABR


Device Classification Name

audiometer

510(k) Number K024205
Device Name AUDIOSCREENER OAE+ABR
Original Applicant
EVEREST BIOMEDICAL INSTRUMENTS CO.
16690 swingley ridge rd.
suite 140
chesterfield, 
MO 
63017

Original Contact randall krohn
Regulation Number 874.1050
Classification Product Code
EWO  
Date Received 12/20/2002
Decision Date 03/07/2003
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