Clearance Summary
HL 188 & HL 189 BODY FAT METER received FDA 510(k) clearance under submission number K043414, sponsored by Health & Life Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2005-02-09.
- Submission: K043414
- Applicant / Sponsor: Health & Life Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 2005-02-09
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.