510(k) K193056
K193056 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "Puritan Bennett 980 Series Ventilator System". The FDA issued a decision of Substantially Equivalent on Nov 20, 2020. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Covidien, LLC has 224 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 20, 2020
- Date Received
- Nov 1, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Continuous, Facility Use
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type
- 510(k)