Clearance Summary
FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE received FDA 510(k) clearance under submission number K161314, sponsored by Flexicare Medical Limited.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2016-07-06.
- Submission: K161314
- Applicant / Sponsor: Flexicare Medical Limited.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5450
- Decision date: 2016-07-06
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.