510(k) K034026— RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS

Substantially Equivalent

Fisher & Paykel Healthcare, Ltd.

Clearance details

Applicant: Fisher & Paykel Healthcare, Ltd.
Product code: Code BZE
Advisory panel: Anesthesiology
Date received: 2003-12-29
Decision date: 2005-01-12
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.