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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier, Physiological Signal
510(k) Number K912436
Device Name AM-PAK
Applicant
Cns, Inc.
1250 Park Rd.
Chanhassen,  MN  55317
Applicant Contact JOHN F STOLTE
Correspondent
Cns, Inc.
1250 Park Rd.
Chanhassen,  MN  55317
Correspondent Contact JOHN F STOLTE
Regulation Number882.1835
Classification Product Code
GWL  
Date Received06/03/1991
Decision Date 10/18/1991
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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