ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS— 510(k) K122432

Substantially Equivalent

Fisher & Paykel Healthcare, Ltd.

FDA 510(k) clearance K122432 for ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS, Substantially Equivalent on 2012-12-06. Applicant: Fisher & Paykel Healthcare, Ltd..

Clearance details

Applicant: Fisher & Paykel Healthcare, Ltd.
Product code: Code BZE
Advisory panel: Anesthesiology
Date received: 2012-08-10
Decision date: 2012-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manukau, NZ

Download summary PDF View on FDA.gov ↗

Adverse events under product code BZE

product code BZE

Death: 4
Malfunction: 910
Other: 1
Total: 915

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.