Clearance Summary
B-SMART, MODEL B-01 received FDA 510(k) clearance under submission number K031128, sponsored by Macosta Medical USA, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2004-01-15.
- Submission: K031128
- Applicant / Sponsor: Macosta Medical USA, LLC
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5140
- Decision date: 2004-01-15
Classification & Regulation
This clearance is catalogued under FDA product code CAZ and 21 CFR 868.5140, within the Anesthesiology review panel as a Class II device.