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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 K133872
Device Name ARIA WIFI SMART SCALE
Applicant
FITBIT, INC.
2995 STEVEN MARTIN DRIVE
FAIRFAX,  VA  22031
Applicant Contact Diane Horwitz
Correspondent
FITBIT, INC.
2995 STEVEN MARTIN DRIVE
FAIRFAX,  VA  22031
Correspondent Contact Diane Horwitz
Regulation Number870.2770
Classification Product Code
MNW  
Date Received12/20/2013
Decision Date 06/02/2014
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
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