Body Fat Analyzer Model TBF-105
FDA 510(k) K930599 · Tanita Corp. of America
510(k) numberK930599
Submission
- Device name
- Body Fat Analyzer Model TBF-105
- Applicant
- Tanita Corp. of America
Skokie, IL, US - Received
- February 5, 1993
- Decision date
- November 1, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DSB – Plethysmograph, Impedance
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2770
- Specialty
- Cardiovascular
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More from Zynex Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K040778 | Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9)MNW · Traditional | 12/23/2004SE |
| K040978 | Tanita Scale Plus Body Fat Monitor with Body Water PercentageMNW · Traditional | 07/22/2004SE |
| K033157 | Tanita Segmental Body Composition Analyzer, Model BC-418MNW · Traditional | 04/08/2004SE |
| K014009 | Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate ScaleMNW · Traditional | 06/24/2002SE |
| K932572 | Digital Baby Scale Model BLB-12FRW · Traditional | 11/16/1993SE |
Questions and answers
When was Body Fat Analyzer Model TBF-105 cleared by the FDA?
Body Fat Analyzer Model TBF-105 (K930599) received a 510(k) decision of Substantially Equivalent on November 1, 1994, 634 days after the submission was received.
What is the product code of K930599?
The FDA product code is DSB – Plethysmograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2770.