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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 K881968
Device Name BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER
Applicant
Biodynamics Corp.
2405 140th Ave. NE, #101
Bellevue,  WA  98005
Applicant Contact EDWARD M RIFKIN
Correspondent
Biodynamics Corp.
2405 140th Ave. NE, #101
Bellevue,  WA  98005
Correspondent Contact EDWARD M RIFKIN
Regulation Number870.2770
Classification Product Code
DSB  
Date Received05/11/1988
Decision Date 07/28/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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