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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 K780150
Device Name NEONATAL SCREENING AUDIOMETER
Applicant
TELEDIAGNOSTIC SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
TELEDIAGNOSTIC SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.1050
Classification Product Code
EWO  
Date Received01/30/1978
Decision Date 02/13/1978
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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