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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 K945689
Device Name GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 2000 PERSONAL DIGITAL AUDIOMETER(TM)
Applicant
CALMED TECHNOLOGY, INC.
29411 KOHOUTEK WAY
UNION CITY,  CA  94587
Applicant Contact LISA S JONES
Correspondent
CALMED TECHNOLOGY, INC.
29411 KOHOUTEK WAY
UNION CITY,  CA  94587
Correspondent Contact LISA S JONES
Regulation Number874.1050
Classification Product Code
EWO  
Date Received11/21/1994
Decision Date 02/08/1995
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
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