Clearance Summary
SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) received FDA 510(k) clearance under submission number K123614, sponsored by Trudell Medical Intl.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2013-03-11.
- Submission: K123614
- Applicant / Sponsor: Trudell Medical Intl.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5630
- Decision date: 2013-03-11
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.