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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Hearing Aid / Earphone And Analysis Systems
510(k) Number K872633
Device Name MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM
Applicant
Hearing Health Care Program
Bldg. 270-2a-10, 3m Center
St. Paul.,  MN  55144
Applicant Contact STOVALL, PHD
Correspondent
Hearing Health Care Program
Bldg. 270-2a-10, 3m Center
St. Paul.,  MN  55144
Correspondent Contact STOVALL, PHD
Regulation Number874.3310
Classification Product Code
ETW  
Date Received07/06/1987
Decision Date 09/16/1987
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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