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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 K052066
Device Name CEEGRAPH/SLEEPSCAN NETLINK TRAVELER
Original Applicant
BIO-LOGIC SYSTEMS CORP.
one bio-logic plaza
mundelein,  IL  60060 -3700
Original Contact norman e brunner
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received08/01/2005
Decision Date 08/26/2005
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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