Clearance Summary
POLARIS 100/200 received FDA 510(k) clearance under submission number K123776, sponsored by Drager Medical GmbH. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2013-03-08.
- Submission: K123776
- Applicant / Sponsor: Drager Medical GmbH
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 2013-03-08
Classification & Regulation
This clearance is catalogued under FDA product code FTD and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.