Clearance Summary
UNILECT, MONITAB AND BIOTRACE-HR received FDA 510(k) clearance under submission number K944497, sponsored by Msb , 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 1996-05-17.
- Submission: K944497
- Applicant / Sponsor: Msb , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 1996-05-17
Classification & Regulation
This clearance is catalogued under FDA product code DRX and 21 CFR 870.2360, within the Cardiovascular review panel as a Class II device.