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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K131045
Device Name ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE
Applicant
Cardiac Designs, LLC
57 Lazy Brook Rd.
Monroe,  CT  06468
Applicant Contact RAYMOND J KELLY, IV
Correspondent
Cardiac Designs, LLC
57 Lazy Brook Rd.
Monroe,  CT  06468
Correspondent Contact RAYMOND J KELLY, IV
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Code
DPS  
Date Received04/15/2013
Decision Date 05/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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