AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER— 510(k) K051226

Substantially Equivalent

Cardinalhealth

FDA 510(k) clearance K051226 for AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER, Substantially Equivalent on 2005-11-17. Applicant: Cardinalhealth.

Clearance details

Applicant: Cardinalhealth
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2005-05-12
Decision date: 2005-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcgaw Park, IL, US

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Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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.