Clearance Summary
ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) received FDA 510(k) clearance under submission number K232015, sponsored by Atmos Medizintechnik GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2023-08-03.
- Submission: K232015
- Applicant / Sponsor: Atmos Medizintechnik GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4760
- Decision date: 2023-08-03
Classification & Regulation
This clearance is catalogued under FDA product code EOB and 21 CFR 874.4760, within the Ear, Nose, Throat review panel as a Class II device.