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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 K011439
Device Name MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR
Applicant
CARDIODYNAMICS INTERNATIONAL CORP.
6175 NANCY RIDGE DR., #300
SAN DIEGO,  CA  92121
Applicant Contact BRIAN PARK
Correspondent
CARDIODYNAMICS INTERNATIONAL CORP.
6175 NANCY RIDGE DR., #300
SAN DIEGO,  CA  92121
Correspondent Contact BRIAN PARK
Regulation Number870.2770
Classification Product Code
DSB  
Date Received05/10/2001
Decision Date 11/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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