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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Spectrum, Electroencephalogram Signal
510(k) Number K854160
Device Name CNS-16 & LTM 1.0 SOFTWARE
Applicant
Cns, Inc.
7090 Shady Oak Rd.
Eden Prairie,  MN  55344
Applicant Contact DANIEL E COHEN
Correspondent
Cns, Inc.
7090 Shady Oak Rd.
Eden Prairie,  MN  55344
Correspondent Contact DANIEL E COHEN
Regulation Number882.1420
Classification Product Code
GWS  
Date Received10/11/1985
Decision Date 01/10/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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