Evite XL
FDA 510(k) K083050 · Draeger Medical AG & Co. KG
510(k) numberK083050
Submission
- Device name
- Evite XL
- Applicant
- Draeger Medical AG & Co. KG
Telford, PA, US - Received
- October 14, 2008
- Decision date
- December 29, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CBK – Ventilator, Continuous, Facility Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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Questions and answers
When was Evite XL cleared by the FDA?
Evite XL (K083050) received a 510(k) decision of Substantially Equivalent on December 29, 2008, 76 days after the submission was received.
What is the product code of K083050?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.