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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 K111180
Device Name VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY
Applicant
Vasomedical, Inc.
180 Linden Ave.
Westbury,  NY  11590
Applicant Contact RICHARD E GORDON
Correspondent
Vasomedical, Inc.
180 Linden Ave.
Westbury,  NY  11590
Correspondent Contact RICHARD E GORDON
Regulation Number870.2800
Classification Product Code
DSH  
Date Received04/27/2011
Decision Date 06/28/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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