K121891

Substantially Equivalent

NEWPORT AURA VENTILATOR

Applicant: Newport Medical Instruments, Inc.
Product code: CBK
Advisory panel: Anesthesiology
Date received: 2012-06-29
Decision date: 2012-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

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.