Clearance Summary
SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW) received FDA 510(k) clearance under submission number K113542, sponsored by Salter Labs, Arvin Facility. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2012-02-10.
- Submission: K113542
- Applicant / Sponsor: Salter Labs, Arvin Facility
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5450
- Decision date: 2012-02-10
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.