SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1— 510(k) K180098

Substantially Equivalent

Maquet Critical Care AB

FDA 510(k) clearance K180098 for SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1, Substantially Equivalent on 2019-03-19. Applicant: Maquet Critical Care AB.

Clearance details

Applicant: Maquet Critical Care AB
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 2018-01-16
Decision date: 2019-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solna, SE

Download summary PDF View on FDA.gov ↗

Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.