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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 K042849
Device Name CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD)
Applicant
Cardiobiomedical Corporation
2 Briar Ln.
Natick,  MA  01760
Applicant Contact JAMES F MONGIGARDO
Correspondent
Cardiobiomedical Corporation
2 Briar Ln.
Natick,  MA  01760
Correspondent Contact JAMES F MONGIGARDO
Regulation Number870.1425
Classification Product Code
DQK  
Date Received10/15/2004
Decision Date 01/13/2005
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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