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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Neurological
510(k) Number K942249
Device Name CLARUS NEUROPEN MODEL 2120
Applicant
Clarus Medical Systems, Inc.
1000 Boone Ave. N.
#100
Minneapolis,  MN  55427
Applicant Contact JOHN V HOEK
Correspondent
Clarus Medical Systems, Inc.
1000 Boone Ave. N.
#100
Minneapolis,  MN  55427
Correspondent Contact JOHN V HOEK
Regulation Number882.1480
Classification Product Code
GWG  
Date Received05/09/1994
Decision Date 11/04/1994
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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