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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 K890497
Device Name MODEL 20-P EXTENDED HIGH FREQUENCY AUDIOMETER
Applicant
Monitor/Demlar
437 Dimmocks Mill Rd.
Hillsborough,  NC  27278
Applicant Contact MACK J PRESLAR
Correspondent
Monitor/Demlar
437 Dimmocks Mill Rd.
Hillsborough,  NC  27278
Correspondent Contact MACK J PRESLAR
Regulation Number874.1050
Classification Product Code
EWO  
Date Received02/01/1989
Decision Date 06/06/1989
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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