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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 K860829
Device Name CNS 4/8 AND CT 48.1 SOFTWARE
Applicant
CNS, INC.
7090 SHADY OAK RD.
EDEN PRAIRIE,  MN  55344
Applicant Contact COHEN, MD
Correspondent
CNS, INC.
7090 SHADY OAK RD.
EDEN PRAIRIE,  MN  55344
Correspondent Contact COHEN, MD
Regulation Number882.1420
Classification Product Code
GWS  
Date Received03/05/1986
Decision Date 05/29/1986
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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