IVENT 201 PORTABLE VENTILATOR— 510(k) K021981

Substantially Equivalent

Versamed , Ltd.

FDA 510(k) clearance K021981 for IVENT 201 PORTABLE VENTILATOR, Substantially Equivalent on 2003-08-13. Applicant: Versamed , Ltd..

Clearance details

Applicant: Versamed , Ltd.
Product code: Code NOU
Advisory panel: Anesthesiology
Date received: 2002-06-17
Decision date: 2003-08-13
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Kadima, IL

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Adverse events under product code NOU

product code NOU

Death: 65
Injury: 138
Malfunction: 3,664
Other: 1
Total: 3,868

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.