The following data is part of a premarket notification filed by Fitbit, Inc. with the FDA for Aria Wifi Smart Scale.
Device ID | K133872 |
510k Number | K133872 |
Device Name: | ARIA WIFI SMART SCALE |
Classification | Analyzer, Body Composition |
Applicant | FITBIT, INC. 2995 STEVEN MARTIN DRIVE Fairfax, VA 22031 |
Contact | Diane Horwitz |
Correspondent | Diane Horwitz FITBIT, INC. 2995 STEVEN MARTIN DRIVE Fairfax, VA 22031 |
Product Code | MNW |
CFR Regulation Number | 870.2770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-12-20 |
Decision Date | 2014-06-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00810351028895 | K133872 | 000 |