F&P Visairo NIV Mask Range— 510(k) K203449

Substantially Equivalent

Fisher & Paykel Healthcare, Ltd.

FDA 510(k) clearance K203449 for F&P Visairo NIV Mask Range, Substantially Equivalent on 2021-04-14. Applicant: Fisher & Paykel Healthcare, Ltd..

Clearance details

Applicant: Fisher & Paykel Healthcare, Ltd.
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 2020-11-23
Decision date: 2021-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, NZ

Download summary PDF View on FDA.gov ↗

Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

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.