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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 K111096
Device Name VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY
Original Applicant
VASOMEDICAL, INC.
180 linden ave.
westbury,  NY  11590
Original Contact richard e gordon
Regulation Number870.2800
Classification Product Code
DSH  
Subsequent Product Code
DXN  
Date Received04/20/2011
Decision Date 06/24/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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