MODIFICATION TO AVEA VENTILATOR— 510(k) K073069

Substantially Equivalent

Viasys Respiratory Care, Inc.

FDA 510(k) clearance K073069 for MODIFICATION TO AVEA VENTILATOR, Substantially Equivalent on 2008-01-25. Applicant: Viasys Respiratory Care, Inc..

Clearance details

Applicant: Viasys Respiratory Care, Inc.
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 2007-10-30
Decision date: 2008-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Spring, CA, US

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Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

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.