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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Air Displacement For Body Composition Analysis
510(k) Number K032610
Device Name MODIFIED SONAMET BODY COMPOSITION ANALYZER
Applicant
Life Measurement, Inc.
2081 Longden Cir.
Los Altos,  CA  94024
Applicant Contact SHELIA W PICKERING
Correspondent
Life Measurement, Inc.
2081 Longden Cir.
Los Altos,  CA  94024
Correspondent Contact SHELIA W PICKERING
Regulation Number870.2770
Classification Product Code
OAC  
Date Received08/25/2003
Decision Date 03/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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