HYGEIA-5 OXYGEN CONCENTRATOR— 510(k) K081267

Substantially Equivalent

Kedl Internation Limited

FDA 510(k) clearance K081267 for HYGEIA-5 OXYGEN CONCENTRATOR, Substantially Equivalent on 2008-09-23. Applicant: Kedl Internation Limited.

Clearance details

Applicant: Kedl Internation Limited
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2008-05-05
Decision date: 2008-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Myers, FL, US

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.