Oxygen concentrator— 510(k) K222920

Substantially Equivalent

Zhengzhou Olive Electronic Technology Co., Ltd.

FDA 510(k) clearance K222920 for Oxygen concentrator, Substantially Equivalent on 2023-07-20. Applicant: Zhengzhou Olive Electronic Technology Co., Ltd..

Clearance details

Applicant: Zhengzhou Olive Electronic Technology Co., Ltd.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2022-09-26
Decision date: 2023-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhenghou, CN

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.