Clearance Summary
Respire Pink AT (Hard, Hard/Soft, EF) received FDA 510(k) clearance under submission number K192127, sponsored by Respire Medical Holdings. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2020-02-05.
- Submission: K192127
- Applicant / Sponsor: Respire Medical Holdings
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 2020-02-05
Classification & Regulation
This clearance is catalogued under FDA product code LRK and 21 CFR 872.5570, within the Dental review panel as a Class II device.