510(k) K123781
K123781 is an FDA 510(k) premarket notification submitted by Zhongshan Transtek Electronics Co., Ltd. for the device "TRANSTEK GLASS BODY FAT ANALYZER". The FDA issued a decision of Substantially Equivalent on January 9, 2013. The device falls under product code MNW (Analyzer, Body Composition), a Class II device regulated under 21 CFR 870.2770. Zhongshan Transtek Electronics Co., Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 2013
- Date Received
- December 10, 2012
- Clearance Type
- Special
- 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