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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 K013137
Device Name ALGO 3 NEWBORN HEARING SCREENER
Applicant
NATUS MEDICAL, INC.
1501 INDUSTRIAL RD.
SAN CARLOS,  CA  94070
Applicant Contact SHEILA RAMERMAN
Correspondent
NATUS MEDICAL, INC.
1501 INDUSTRIAL RD.
SAN CARLOS,  CA  94070
Correspondent Contact SHEILA RAMERMAN
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received09/19/2001
Decision Date 10/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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