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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Index-Generating Electroencephalograph Software
510(k) Number K010965
Device Name A-LINE AEP MONITOR
Applicant
ALARIS MEDICAL SYSTEMS, INC.
10221 WATERIDGE CIR.
SAN DIEGO,  CA  92121
Applicant Contact RENEE FLUET
Correspondent
ALARIS MEDICAL SYSTEMS, INC.
10221 WATERIDGE CIR.
SAN DIEGO,  CA  92121
Correspondent Contact RENEE FLUET
Regulation Number882.1400
Classification Product Code
OLW  
Subsequent Product Code
OMC  
Date Received04/02/2001
Decision Date 06/27/2001
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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