Clearance Summary
RESPICONNECT ADAPTER received FDA 510(k) clearance under submission number K140919, sponsored by Trudell Medical Int'L. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2014-08-15.
- Submission: K140919
- Applicant / Sponsor: Trudell Medical Int'L
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5630
- Decision date: 2014-08-15
Classification & Regulation
This clearance is catalogued under FDA product code CAF and 21 CFR 868.5630, within the Anesthesiology review panel as a Class II device.