Clearance Summary
THE AQUA-AIR PROFESSIONAL FIELD UNIT(S) received FDA 510(k) clearance under submission number K950175, sponsored by Aqua-Air Medical Devices, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1995-04-18.
- Submission: K950175
- Applicant / Sponsor: Aqua-Air Medical Devices, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1995-04-18
Classification & Regulation
This clearance is catalogued under FDA product code EIA and 21 CFR 872.6640, within the Dental review panel as a Class I device.