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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 K844015
Device Name CEREBRAL TRACER 1500 & CT 1.0 SOFTWARE
Applicant
Cns, Inc.
7090 Shady Oak Rd.
Eden Prairie,  MN  55344
Applicant Contact RONALD PODRAZA
Correspondent
Cns, Inc.
7090 Shady Oak Rd.
Eden Prairie,  MN  55344
Correspondent Contact RONALD PODRAZA
Regulation Number882.1420
Classification Product Code
GWS  
Date Received10/12/1984
Decision Date 12/17/1984
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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