F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version— 510(k) K173060

Substantially Equivalent

Fisher and Paykel Healthcare Limited

FDA 510(k) clearance K173060 for F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version, Substantially Equivalent on 2018-01-25. Applicant: Fisher and Paykel Healthcare Limited.

Clearance details

Applicant: Fisher and Paykel Healthcare Limited
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 2017-09-28
Decision date: 2018-01-25
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.