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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 K934343
Device Name GLASER RT60, RT80, RT150 AUDIOMETER
Applicant
Glaser Instruments AG
Sihltalstrasse 74
Ch-8135 Langnau/Zurich
Switzerland,  CH
Applicant Contact ROBERT P GLASER
Correspondent
Glaser Instruments AG
Sihltalstrasse 74
Ch-8135 Langnau/Zurich
Switzerland,  CH
Correspondent Contact ROBERT P GLASER
Regulation Number874.1050
Classification Product Code
EWO  
Date Received09/07/1993
Decision Date 01/21/1994
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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