K090248

Substantially Equivalent

BIPAP AUTOSV

Applicant: Respironics Inc., Sleep & Home Respiratory Group
Product code: MNS
Advisory panel: Anesthesiology
Date received: 2009-02-02
Decision date: 2009-03-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Murrysville, PA, US

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.