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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Counter-Pulsating, External
510(k) Number K020857
Device Name EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER
Applicant
Vasomedical, Inc.
180 Linden Ave.
Westbury,  NY  11590
Applicant Contact THOMAS R VARRICCHIONE
Correspondent
Vasomedical, Inc.
180 Linden Ave.
Westbury,  NY  11590
Correspondent Contact THOMAS R VARRICCHIONE
Regulation Number870.5225
Classification Product Code
DRN  
Date Received03/18/2002
Decision Date 06/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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