2300 SERIES MGO PORTABLE OXYGEN— 510(k) K134023

Substantially Equivalent

Ultra Electronics Limited Precision Air & Land SY

FDA 510(k) clearance K134023 for 2300 SERIES MGO PORTABLE OXYGEN, Substantially Equivalent on 2014-04-25. Applicant: Ultra Electronics Limited Precision Air & Land SY.

Clearance details

Applicant: Ultra Electronics Limited Precision Air & Land SY
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2013-12-30
Decision date: 2014-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheltenham, Gloucestershire, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAW

product code CAW

Death: 204
Injury: 573
Malfunction: 1,400
Other: 6
Total: 2,183

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.