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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Impedance
510(k) Number K051228
Device Name BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG
Applicant
Cardiodynamics International Corp.
6175 Nancy Ridge Dr., #300
San Diego,  CA  92121
Applicant Contact DENNIS HEPP
Correspondent
Cardiodynamics International Corp.
6175 Nancy Ridge Dr., #300
San Diego,  CA  92121
Correspondent Contact DENNIS HEPP
Regulation Number870.2770
Classification Product Code
DSB  
Date Received05/13/2005
Decision Date 06/10/2005
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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