ACUTEVENTILATOR— 510(k) K012271

Substantially Equivalent

Impoex International, Ltd.

FDA 510(k) clearance K012271 for ACUTEVENTILATOR, Substantially Equivalent on 2002-10-04. Applicant: Impoex International, Ltd..

Clearance details

Applicant: Impoex International, Ltd.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 2001-07-19
Decision date: 2002-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Little River, SC, US

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Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

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.