510(k) K062652
K062652 is an FDA 510(k) premarket notification submitted by Tanita Corporation Of America for the device "INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR". The FDA issued a decision of Substantially Equivalent on Dec 28, 2006. 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
- Dec 28, 2006
- Date Received
- Sep 7, 2006
- 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)