K103767

Substantially Equivalent

DUAL HEATED INFANT VREATHING CIROUITS

Applicant: Fisher & Paykel Healthcare, Ltd.
Product code: BZE
Advisory panel: Anesthesiology
Date received: 2010-12-23
Decision date: 2012-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, NZ

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.