AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM— 510(k) K050994

Substantially Equivalent

Cardinalhealth

FDA 510(k) clearance K050994 for AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM, Substantially Equivalent on 2005-08-03. Applicant: Cardinalhealth.

Clearance details

Applicant: Cardinalhealth
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2005-04-19
Decision date: 2005-08-03
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.