510(k) K040978
K040978 is an FDA 510(k) premarket notification submitted by Tanita Corp. of America for the device "TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE". The FDA issued a decision of Substantially Equivalent on July 22, 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
- July 22, 2004
- Date Received
- April 15, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Analyzer, Body Composition
- Device Class
- Class II
- Regulation Number
- 870.2770
- Review Panel
- GU
- Submission Type