Clearance Summary
ELF received FDA 510(k) clearance under submission number K853433, sponsored by Cardio-Respiratory. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1985-11-29.
- Submission: K853433
- Applicant / Sponsor: Cardio-Respiratory
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1890
- Decision date: 1985-11-29
Classification & Regulation
This clearance is catalogued under FDA product code BTY and 21 CFR 868.1890, within the Anesthesiology review panel as a Class II device.