Clearance Summary
BODY FAT SCALE MODEL SF-371 received FDA 510(k) clearance under submission number K122976, sponsored by Shenzhen Belter Health Measurement and Analysis TE. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2013-01-04.
- Submission: K122976
- Applicant / Sponsor: Shenzhen Belter Health Measurement and Analysis TE
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 2013-01-04
Classification & Regulation
This clearance is catalogued under FDA product code MNW and 21 CFR 870.2770, within the Cardiovascular review panel as a Class II device.