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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K092785
Device Name COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301
Applicant
Vasomedical, Inc.
180 Linden Ave.
Westbury,  NY  11590
Applicant Contact RICHARD GORDON
Correspondent
Vasomedical, Inc.
180 Linden Ave.
Westbury,  NY  11590
Correspondent Contact RICHARD GORDON
Regulation Number870.2800
Classification Product Code
DSH  
Subsequent Product Code
DXN  
Date Received09/10/2009
Decision Date 04/02/2010
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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