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FDA 510(k) Application Details - K133872
Device Classification Name
Analyzer, Body Composition
More FDA Info for this Device
510(K) Number
K133872
Device Name
Analyzer, Body Composition
Applicant
FITBIT, INC.
2995 STEVEN MARTIN DRIVE
FAIRFAX, VA 22031 US
Other 510(k) Applications for this Company
Contact
Diane Horwitz
Other 510(k) Applications for this Contact
Regulation Number
870.2770
More FDA Info for this Regulation Number
Classification Product Code
MNW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/20/2013
Decision Date
06/02/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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