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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 K950888
Device Name SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY
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 Received02/28/1995
Decision Date 03/21/1995
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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