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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Body Composition
510(k) Number K101807
Device Name STAYHEALTHY BODY COMPOSITION MONITOR-BCM
Applicant
Stayhealthy, Inc.
724 E. Huntington Dr.
Monrovia,  CA  91016
Applicant Contact JESUS FARINAS
Correspondent
Stayhealthy, Inc.
724 E. Huntington Dr.
Monrovia,  CA  91016
Correspondent Contact JESUS FARINAS
Regulation Number870.2770
Classification Product Code
MNW  
Date Received06/28/2010
Decision Date 01/26/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Clinical Trials NCT01209923
NCT01209936
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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