Evita V800, Evita V600
by Draegerwerk AG & CO Kgaa EUDAMED510(k)
Active
510(k) K222024
Overview
The Evita V800 and Evita V600 are continuous-use ventilators designed for facility-based respiratory support. These devices are classified as Class II medical devices under FDA regulations and are intended for mechanical ventilation of patients requiring assisted or controlled breathing, including those in critical care, operating rooms, and intensive care units.
The Evita V800 and Evita V600 are supplied as reusable medical devices and are intended for facility use only. They are regulated under the FDA’s 510(k) clearance process and the EU’s Medical Device Regulation (MDR). These ventilators are not single-use and require proper maintenance, cleaning, and calibration as per manufacturer guidelines. They are designed for use in environments where MRI compatibility is not required, and their operation is governed by the FDA’s regulation number 868.5895.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK222024 | Date16 May 2023 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CBK
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5895
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Draegerwerk AG & Co. KGaA
Questions
Are the Evita V800 and Evita V600 ventilators designed for single-use or reusable facility-based use, and what does this mean for maintenance requirements?
The Evita V800 and Evita V600 are reusable medical devices intended exclusively for facility-based use. This means they are not single-use and require regular maintenance, cleaning, and calibration as outlined in the manufacturer’s guidelines to ensure safe and reliable operation over time.
What types of clinical environments are these ventilators intended for, and how does their design accommodate those settings?
The Evita V800 and Evita V600 are designed for facility-based respiratory support, including critical care units, operating rooms, and intensive care settings. They are not MRI-compatible, so they are best suited for environments where magnetic resonance imaging is not a primary concern. Their design aligns with FDA’s Class II classification for continuous-use ventilators.
How are the Evita V800 and Evita V600 regulated in the U.S. and Europe, and what does this mean for purchasing or clinical use?
In the U.S., these ventilators are regulated under the FDA’s 510(k) clearance process and classified as Class II devices, with a decision date of May 16, 2023. In Europe, they comply with the Medical Device Regulation (MDR). This means they undergo rigorous pre-market review to ensure safety and performance, but the specific regulatory status does not alter their clinical purpose—mechanical ventilation for assisted or controlled breathing.
What special considerations should clinicians or facilities keep in mind when storing or handling these ventilators?
Since the Evita V800 and Evita V600 are reusable, proper storage involves keeping them in a clean, dry environment to prevent contamination or damage. Facilities must follow Draeger’s maintenance protocols to ensure functionality, including calibration and periodic servicing. Unlike single-use devices, these require dedicated space and procedures to maintain hygiene and operational readiness.