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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 K940999
Device Name PRODIGIT 2000
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 Received03/04/1994
Decision Date 04/22/1994
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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