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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 K013863
Device Name CRYSTAL MONITOR MODEL 16
Applicant
CLEVELAND MEDICAL DEVICES, INC.
11000 CEDAR AVE., SUITE 130
CLEVELAND,  OH  44106
Applicant Contact ROBERT N SCHMIDT
Correspondent
CLEVELAND MEDICAL DEVICES, INC.
11000 CEDAR AVE., SUITE 130
CLEVELAND,  OH  44106
Correspondent Contact ROBERT N SCHMIDT
Regulation Number882.1400
Classification Product Code
OMC  
Subsequent Product Code
OLV  
Date Received11/21/2001
Decision Date 02/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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