Clearance Summary
BIOTRACE-N, NS, 410 AND RT received FDA 510(k) clearance under submission number K944496, 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 1996-05-16.
- Submission: K944496
- Applicant / Sponsor: Msb , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 1996-05-16
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.