Oxymag - Transport and Emergency Ventilator— 510(k) K221634

Substantially Equivalent

Magnamed Tecnologia Medica S/A

FDA 510(k) clearance K221634 for Oxymag - Transport and Emergency Ventilator, Substantially Equivalent on 2023-05-24. Applicant: Magnamed Tecnologia Medica S/A.

Clearance details

Applicant: Magnamed Tecnologia Medica S/A
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 2022-06-06
Decision date: 2023-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cotia, BR

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

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.