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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 K130952
Device Name PRECISION ONE LIFECARE; DETECTO; DETECTO
Applicant
Precision One Lifecare, Ltd.
P.O.Box 3515
Redmond,  WA  98073
Applicant Contact STEVEN CHERNOFF
Correspondent
Precision One Lifecare, Ltd.
P.O.Box 3515
Redmond,  WA  98073
Correspondent Contact STEVEN CHERNOFF
Regulation Number870.2770
Classification Product Code
MNW  
Date Received04/05/2013
Decision Date 09/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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