Clearance Summary
KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530 received FDA 510(k) clearance under submission number K081587, sponsored by Krell Precision (Yang Zhou) 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 2008-10-24.
- Submission: K081587
- Applicant / Sponsor: Krell Precision (Yang Zhou) Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 2008-10-24
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.