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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 K003469
Device Name EECP THERAPY SYSTEM, MODEL TS3
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 Received11/08/2000
Decision Date 12/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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