510(k) K131394
K131394 is an FDA 510(k) premarket notification submitted by Guangdong Transtek Medical Electronics Co., Ltd. for the device "TRANSTEK GLASS BODY FAT ANALYZER". The FDA issued a decision of Substantially Equivalent on September 18, 2013. The device falls under product code MNW (Analyzer, Body Composition), a Class II device regulated under 21 CFR 870.2770. Guangdong Transtek Medical Electronics Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 2013
- Date Received
- May 15, 2013
- 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