510(k) K033157
K033157 is an FDA 510(k) premarket notification submitted by Tanita Corp. of America for the device "TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418". The FDA issued a decision of Substantially Equivalent on April 8, 2004. The device falls under product code MNW (Analyzer, Body Composition), a Class II device regulated under 21 CFR 870.2770. Tanita Corp. of America has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 2004
- Date Received
- September 30, 2003
- 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