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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 K972320
Device Name BIOZ SYSTEM & BIOZ PORTABLE
Applicant
Cardiodynamics International Corp.
6155 Cornerstone Court E.
Suite 125
San Diego,  CA  92121
Applicant Contact JAMES BARLEY
Correspondent
Cardiodynamics International Corp.
6155 Cornerstone Court E.
Suite 125
San Diego,  CA  92121
Correspondent Contact JAMES BARLEY
Regulation Number870.2770
Classification Product Code
DSB  
Date Received06/23/1997
Decision Date 09/11/1997
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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