Clearance Summary
ARC 400 received FDA 510(k) clearance under submission number K193591, sponsored by Bowa-Electronics GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2020-04-02.
- Submission: K193591
- Applicant / Sponsor: Bowa-Electronics GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2020-04-02
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.