Clearance Summary
BODYSTAT received FDA 510(k) clearance under submission number K971554, sponsored by Bodystat , 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 1997-11-26.
- Submission: K971554
- Applicant / Sponsor: Bodystat , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 1997-11-26
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.