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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 K030823
Device Name ALGO 3I NEWBORN HEARING SCREENER
Applicant
Natus Medical, Inc.
1501 Industrial Rd.
San Carlos,  CA  94070
Applicant Contact RON KOHLHARDT
Correspondent
Natus Medical, Inc.
1501 Industrial Rd.
San Carlos,  CA  94070
Correspondent Contact RON KOHLHARDT
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received03/14/2003
Decision Date 04/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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