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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Standard Polysomnograph With Electroencephalograph
510(k) Number K003681
Device Name BIO-LOGIC SLEEPSCAN NETLINK
Applicant
BIO-LOGIC SYSTEMS CORP.
ONE BIO-LOGIC PLAZA
MUNDELEIN,  IL  60060 -3700
Applicant Contact NORMAN E BRUNNER
Correspondent
BIO-LOGIC SYSTEMS CORP.
ONE BIO-LOGIC PLAZA
MUNDELEIN,  IL  60060 -3700
Correspondent Contact NORMAN E BRUNNER
Regulation Number882.1400
Classification Product Code
OLV  
Date Received11/30/2000
Decision Date 12/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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