Clearance Summary
BICORE SMARTCATH INTRATRACHEAL CATHETER received FDA 510(k) clearance under submission number K935788, sponsored by Bicore Monitoring Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1995-07-03.
- Submission: K935788
- Applicant / Sponsor: Bicore Monitoring Systems
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5895
- Decision date: 1995-07-03
Classification & Regulation
This clearance is catalogued under FDA product code MOD and 21 CFR 868.5895, within the Anesthesiology review panel as a Class II device.