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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
Predetermined Change
Control Plan Authorized		 No
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