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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K101867
Device Name VICOR PD2I ANALYZER
Applicant
Vicor Technologies, Inc.
261 Madison Ave., 24th Floor
New York,  NY  10016
Applicant Contact GLEN PARK
Correspondent
Vicor Technologies, Inc.
261 Madison Ave., 24th Floor
New York,  NY  10016
Correspondent Contact GLEN PARK
Regulation Number870.2340
Classification Product Code
DPS  
Date Received07/02/2010
Decision Date 04/14/2011
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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