Puritan Bennett 980 Series Ventilator System
FDA 510(k) K131252 · Covidien
510(k) numberK131252
Submission
- Device name
- Puritan Bennett 980 Series Ventilator System
- Applicant
- Covidien
Boulder, CO, US - Received
- May 2, 2013
- Decision date
- February 24, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Puritan Bennett 980 Series Ventilator System cleared by the FDA?
Puritan Bennett 980 Series Ventilator System (K131252) received a 510(k) decision of Substantially Equivalent on February 24, 2014, 298 days after the submission was received.
What is the product code of K131252?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.