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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 K092111
Device Name ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204
Applicant
ENTOMED AB
BARIUMGATAN 29
MALMO,  SE 213 64
Applicant Contact CHARLOTTE MATTISSON
Correspondent
ENTOMED AB
BARIUMGATAN 29
MALMO,  SE 213 64
Correspondent Contact CHARLOTTE MATTISSON
Regulation Number874.1050
Classification Product Code
EWO  
Date Received07/14/2009
Decision Date 10/02/2009
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
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