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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 K900197
Device Name THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER
Applicant
Sound Linked Data, Inc.
5444 Timberlea Blvd.
Mississauga, Ontario
Canada L4w 2tf,  CA
Applicant Contact T MACTAGGART
Correspondent
Sound Linked Data, Inc.
5444 Timberlea Blvd.
Mississauga, Ontario
Canada L4w 2tf,  CA
Correspondent Contact T MACTAGGART
Regulation Number874.1050
Classification Product Code
EWO  
Date Received01/16/1990
Decision Date 04/17/1991
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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