510(k) K090479
K090479 is an FDA 510(k) premarket notification submitted by Tanita Corporation Of America for the device "TANITA BODY COMPOSITION ANALYZER, MODEL SC-331". The FDA issued a decision of Substantially Equivalent on Jul 7, 2009. The device falls under product code MNW (Analyzer, Body Composition), a Class II device regulated under 21 CFR 870.2770. Tanita Corporation Of America has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 7, 2009
- Date Received
- Feb 24, 2009
- 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
- 510(k)