510(k) K180098
K180098 is an FDA 510(k) premarket notification submitted by Maquet Critical Care AB for the device "SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1". The FDA issued a decision of Substantially Equivalent on March 19, 2019. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Maquet Critical Care AB has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 2019
- Date Received
- January 16, 2018
- 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