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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 K863833
Device Name BODY WATCH BODY COMPOSITION ANALYZER MODEL 2010
Applicant
Body Watch, Inc.
405 Summit
Winston-Salem,  NC  27101
Applicant Contact EVERHART
Correspondent
Body Watch, Inc.
405 Summit
Winston-Salem,  NC  27101
Correspondent Contact EVERHART
Regulation Number870.2770
Classification Product Code
DSB  
Date Received09/30/1986
Decision Date 03/17/1987
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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