510(k) K192604
K192604 is an FDA 510(k) premarket notification submitted by Maquet Critica Care AB for the device "Servo-air 4.0 Ventilator System". The FDA issued a decision of Substantially Equivalent on Jun 18, 2020. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 18, 2020
- Date Received
- Sep 20, 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)