Clearance Summary
DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA received FDA 510(k) clearance under submission number K961150, sponsored by Hudson Respiratory Care, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1996-09-10.
- Submission: K961150
- Applicant / Sponsor: Hudson Respiratory Care, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 1996-09-10
Classification & Regulation
This clearance is catalogued under FDA product code CCK and 21 CFR 868.1400, within the Anesthesiology review panel as a Class II device.