K253647
- 510(k) number
- K253647
- Device name
- Evita (V800); Evita (V600)
- Applicant
- Draegerwerk AG & CO Kgaa DE
- Product code
- CBK — Ventilator, Continuous, Facility Use
- Decision date
- 2026-05-07
- Date received
- 2025-11-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253647.pdf
Official FDA record: K253647
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.