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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 K870337
Device Name AUDIOMETER
Applicant
BIO-LOGIC SYSTEMS CORP.
ONE BIO-LOGIC PLAZA
MUNDELEIN,  IL  60060 -3700
Applicant Contact RAVIV, PH.D.
Correspondent
BIO-LOGIC SYSTEMS CORP.
ONE BIO-LOGIC PLAZA
MUNDELEIN,  IL  60060 -3700
Correspondent Contact RAVIV, PH.D.
Regulation Number874.3310
Classification Product Code
ETW  
Date Received01/28/1987
Decision Date 04/16/1987
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
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