JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-07000— 510(k) K090007

Substantially Equivalent

Danyang Jumao Healthcare Equipment Co., Ltd.

FDA 510(k) clearance K090007 for JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-07000, Substantially Equivalent on 2009-07-24. Applicant: Danyang Jumao Healthcare Equipment Co., Ltd..

Clearance details

Applicant: Danyang Jumao Healthcare Equipment Co., Ltd.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2009-01-02
Decision date: 2009-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danyang City,Jiangsu Province, 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.