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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 K936039
Device Name ALGO-2 NEWBORN HEARING SCREENER
Applicant
NATUS MEDICAL, INC.
1501 INDUSTRIAL RD.
SAN CARLOS,  CA  94070
Applicant Contact ROBERT T STONE
Correspondent
NATUS MEDICAL, INC.
1501 INDUSTRIAL RD.
SAN CARLOS,  CA  94070
Correspondent Contact ROBERT T STONE
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received12/20/1993
Decision Date 01/05/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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