Clearance Summary
Evita (V800); Evita (V600) received FDA 510(k) clearance under submission number K253647, sponsored by Draegerwerk AG & CO Kgaa. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2026-05-07.
- Submission: K253647
- Applicant / Sponsor: Draegerwerk AG & CO Kgaa
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5895
- Decision date: 2026-05-07
Classification & Regulation
This clearance is catalogued under FDA product code CBK and 21 CFR 868.5895, within the Anesthesiology review panel as a Class II device.