510(k) K211560— Airvo Nebulizer Adapter

Substantially Equivalent

Fisher & Paykel Healthcare Limited

Clearance details

Applicant: Fisher & Paykel Healthcare Limited
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2021-05-20
Decision date: 2021-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, NZ

Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.