Clearance Summary
OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor received FDA 510(k) clearance under submission number K181571, sponsored by Mark Abramson, D.D.S., 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 2019-04-19.
- Submission: K181571
- Applicant / Sponsor: Mark Abramson, D.D.S., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 2019-04-19
Classification & Regulation
This clearance is catalogued under FDA product code PLC and 21 CFR 872.5570, within the Dental review panel as a Class II device.