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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Auditory, Evoked Response
510(k) Number K233649
Device Name ALGO Pro Newborn Hearing Screener (ALGO Pro)
Applicant
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
2568 Bristol Circle
Oakville,  CA l6h 5s1
Applicant Contact Bronwyn Kelly
Correspondent
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
2568 Bristol Circle
Oakville,  CA l6h 5s1
Correspondent Contact Bronwyn Kelly
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received11/14/2023
Decision Date 03/08/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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