Clearance Summary
SMOOTH-FLO CIRCUIT received FDA 510(k) clearance under submission number K010402, sponsored by Hudson Respiratory Care, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2001-03-14.
- Submission: K010402
- Applicant / Sponsor: Hudson Respiratory Care, Inc.
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5450
- Decision date: 2001-03-14
Classification & Regulation
This clearance is catalogued under FDA product code BTT and 21 CFR 868.5450, within the Anesthesiology review panel as a Class II device.