BIPAP FOCUS— 510(k) K053168

Substantially Equivalent

Respironics (Ireland) Limited

FDA 510(k) clearance K053168 for BIPAP FOCUS, Substantially Equivalent on 2006-01-04. Applicant: Respironics (Ireland) Limited.

Clearance details

Applicant: Respironics (Ireland) Limited
Product code: Code MNS
Advisory panel: Anesthesiology
Date received: 2005-11-14
Decision date: 2006-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code MNS

product code MNS

Death: 344
Injury: 1,160
Malfunction: 8,068
Total: 9,572

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.