F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)— 510(k) K234058

Substantially Equivalent

Fisher & Paykel Healthcare, Ltd.

FDA 510(k) clearance K234058 for F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J), Substantially Equivalent on 2024-08-08. Applicant: Fisher & Paykel Healthcare, Ltd..

Clearance details

Applicant: Fisher & Paykel Healthcare, Ltd.
Product code: Code BTT
Advisory panel: Anesthesiology
Date received: 2023-12-22
Decision date: 2024-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, NZ

Download summary PDF View on FDA.gov ↗

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.