ACUTE CARE FACE MASK, MODEL RT040— 510(k) K060044

Substantially Equivalent

Fisher & Paykel Healthcare, Ltd.

FDA 510(k) clearance K060044 for ACUTE CARE FACE MASK, MODEL RT040, Substantially Equivalent on 2006-04-06. Applicant: Fisher & Paykel Healthcare, Ltd..

Clearance details

Applicant: Fisher & Paykel Healthcare, Ltd.
Product code: Code MNT
Advisory panel: Anesthesiology
Date received: 2006-01-06
Decision date: 2006-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Panmure, Auckland, NZ

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Adverse events under product code MNT

product code MNT

Death: 118
Injury: 324
Malfunction: 25,451
Other: 2
Total: 25,895

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.