HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041— 510(k) K083122

Substantially Equivalent

Fisher & Paykel Healthcare, Ltd.

FDA 510(k) clearance K083122 for HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041, Substantially Equivalent on 2009-03-04. Applicant: Fisher & Paykel Healthcare, Ltd..

Clearance details

Applicant: Fisher & Paykel Healthcare, Ltd.
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 2008-10-22
Decision date: 2009-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Tamaki, NZ

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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.