Clearance Summary
S-Line received FDA 510(k) clearance under submission number K213191, sponsored by Barkey GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2022-05-24.
- Submission: K213191
- Applicant / Sponsor: Barkey GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2022-05-24
Classification & Regulation
This clearance is catalogued under FDA product code LGZ and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.