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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 K930003
Device Name TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES
Applicant
Etymotic Research
61 Martin Ln.
Elk Grove Village,  IL  60007
Applicant Contact EDWIN L DEVILBISS
Correspondent
Etymotic Research
61 Martin Ln.
Elk Grove Village,  IL  60007
Correspondent Contact EDWIN L DEVILBISS
Regulation Number874.1050
Classification Product Code
EWO  
Date Received01/04/1993
Decision Date 06/18/1993
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
Predetermined Change
Control Plan Authorized		 No
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