510(k) K092846— AIRVO SERIES HUMIDIFIERS

Substantially Equivalent

Fisher & Paykel Healthcare, Ltd.

Clearance details

Applicant: Fisher & Paykel Healthcare, Ltd.
Product code: Code BTT
Advisory panel: Anesthesiology
Date received: 2009-09-15
Decision date: 2010-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manukau, NZ

Adverse events under product code BTT

product code BTT

Death: 60
Injury: 152
Malfunction: 7,232
Other: 2
Total: 7,446

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.