Clearance Summary
DRAGER SOLA SERIES, MODELS 1000/700/500/300 received FDA 510(k) clearance under submission number K984611, sponsored by Drager Medizintechnik 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 1999-03-29.
- Submission: K984611
- Applicant / Sponsor: Drager Medizintechnik GmbH
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 1999-03-29
Classification & Regulation
This clearance is catalogued under FDA product code FSY and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.