Clearance Summary
FI02 SENSING MODULE received FDA 510(k) clearance under submission number K944120, sponsored by Core-M, L.P.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1995-05-10.
- Submission: K944120
- Applicant / Sponsor: Core-M, L.P.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1720
- Decision date: 1995-05-10
Classification & Regulation
This clearance is catalogued under FDA product code CCL and 21 CFR 868.1720, within the Anesthesiology review panel as a Class II device.