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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 K070156
Device Name BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100
Applicant
Cardiodynamics International Corp.
6175 Nancy Ridge Dr., #300
San Diego,  CA  92121
Applicant Contact PAUL L SHAFFER
Correspondent
Cardiodynamics International Corp.
6175 Nancy Ridge Dr., #300
San Diego,  CA  92121
Correspondent Contact PAUL L SHAFFER
Regulation Number870.2770
Classification Product Code
DSB  
Subsequent Product Code
DPS  
Date Received01/17/2007
Decision Date 09/26/2007
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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