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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 K001100
Device Name BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH
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 Received04/05/2000
Decision Date 05/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
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