510(k) K930599
K930599 is an FDA 510(k) premarket notification submitted by Tanita Corp. of America for the device "BODY FAT ANALYZER MODEL TBF-105". The FDA issued a decision of Substantially Equivalent on November 1, 1994. The device falls under product code DSB (Plethysmograph, Impedance), 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
- November 1, 1994
- Date Received
- February 5, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plethysmograph, Impedance
- Device Class
- Class II
- Regulation Number
- 870.2770
- Review Panel
- CV
- Submission Type