Clearance Summary
LONG WELL LW-6DXX SERIES BODY FAT ANALYZER received FDA 510(k) clearance under submission number K030203, sponsored by Long Well Electronics Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2003-04-21.
- Submission: K030203
- Applicant / Sponsor: Long Well Electronics Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 2003-04-21
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.