510(k) K133872
K133872 is an FDA 510(k) premarket notification submitted by Fitbit, Inc. for the device "ARIA WIFI SMART SCALE". The FDA issued a decision of Substantially Equivalent on June 2, 2014. The device falls under product code MNW (Analyzer, Body Composition), a Class II device regulated under 21 CFR 870.2770. Fitbit, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 2014
- Date Received
- December 20, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Body Composition
- Device Class
- Class II
- Regulation Number
- 870.2770
- Review Panel
- GU
- Submission Type