510(k) K213825— Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A

Substantially Equivalent

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Clearance details

Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2021-12-08
Decision date: 2023-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danyang, CN

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.