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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K860175
Device Name CD-200 CARDIAC MONITOR
Applicant
Cardio Display Corp.
2000 Shames Dr.
Westbury,  NY  11590
Applicant Contact MILAN KESLER
Correspondent
Cardio Display Corp.
2000 Shames Dr.
Westbury,  NY  11590
Correspondent Contact MILAN KESLER
Regulation Number870.2340
Classification Product Code
DPS  
Date Received01/17/1986
Decision Date 04/15/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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