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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 K962783
Device Name EDEMA SYSTEM
Applicant
Bioanalogics, Inc.
181 40 Smokesignal Dr.
San Diego,  CA  92127
Applicant Contact CAROL L PATTERSON
Correspondent
Bioanalogics, Inc.
181 40 Smokesignal Dr.
San Diego,  CA  92127
Correspondent Contact CAROL L PATTERSON
Regulation Number870.2770
Classification Product Code
DSB  
Date Received07/17/1996
Decision Date 10/23/1997
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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