Rugged Oxygen Generator (ROG) (RO01-00001)— 510(k) K240561

Substantially Equivalent

Molecular Products , Ltd.

FDA 510(k) clearance K240561 for Rugged Oxygen Generator (ROG) (RO01-00001), Substantially Equivalent on 2024-12-06. Applicant: Molecular Products , Ltd..

Clearance details

Applicant: Molecular Products , Ltd.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2024-02-29
Decision date: 2024-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Harlow Essex, 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.