Servo-air Lite Ventilator System— 510(k) K230173

Substantially Equivalent

Maquet Critical Care AB

FDA 510(k) clearance K230173 for Servo-air Lite Ventilator System, Substantially Equivalent on 2023-07-06. Applicant: Maquet Critical Care AB.

Clearance details

Applicant: Maquet Critical Care AB
Product code: Code MNT
Advisory panel: Anesthesiology
Date received: 2023-01-20
Decision date: 2023-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solna, SE

Download summary PDF View on FDA.gov ↗

Adverse events under product code MNT

product code MNT

Death: 118
Injury: 324
Malfunction: 25,451
Other: 2
Total: 25,895

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.