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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reduced- Montage Standard Electroencephalograph
510(k) Number K970672
Device Name CRYSTAL-EEG MODEL 10 (MODEL 10)
Applicant
Cleveland Medical Devices, Inc.
11000 Cedar Ave.
Suite 439
Cleveland,  OH  44106
Applicant Contact ROBERT N SCHMIDT
Correspondent
Cleveland Medical Devices, Inc.
11000 Cedar Ave.
Suite 439
Cleveland,  OH  44106
Correspondent Contact ROBERT N SCHMIDT
Regulation Number882.1400
Classification Product Code
OMC  
Date Received02/24/1997
Decision Date 05/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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