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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name standard polysomnograph with electroencephalograph
510(k) Number K042039
Device Name FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120
Applicant
CLEVELAND MEDICAL DEVICES, INC.
4415 EUCLID AVE
CLEVELAND,  OH  44103
Applicant Contact ROBERT N SCHMIDT
Correspondent
CLEVELAND MEDICAL DEVICES, INC.
4415 EUCLID AVE
CLEVELAND,  OH  44103
Correspondent Contact ROBERT N SCHMIDT
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received07/29/2004
Decision Date 11/17/2004
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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