Evita (V800); Evita (V600)
FDA 510(k) clearance K253647 · decided 2026-05-07
Clearance details
- K-number
- K253647
- Device name
- Evita (V800); Evita (V600)
- Applicant
- Draegerwerk AG & CO Kgaa
- Decision
- Substantially Equivalent
- Date received
- 2025-11-20
- Decision date
- 2026-05-07
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Luebeck, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.