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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Audiometer
510(k) Number K970555
Device Name IL0292 DP ECHOPORT
Applicant
SMITH
P.O. BOX 4341
CROFTON,  MD  21114
Applicant Contact E. J SMITH
Correspondent
SMITH
P.O. BOX 4341
CROFTON,  MD  21114
Correspondent Contact E. J SMITH
Regulation Number874.1050
Classification Product Code
EWO  
Date Received02/13/1997
Decision Date 03/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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