Class Class II
Evita V800, Evita V600 (K222024)
Description
Evita V800, Evita V600 by Draegerwerk AG & CO Kgaa, an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222024
Clearance Date2023-05-16
Clearance TypeTraditional
Product CodeCBK
Regulation Number868.5895
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222024
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Evita V800, Evita V600 (K222024) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K193056 | Puritan Bennett 980 Series Ventilator System | Covidien, LLC | 2020 |
| K093633 | INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE | Draegerwerk AG & CO Kgaa | 2010 |
Trace the full predicate network for K222024
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.