Family of DIMAR DMAX NIV masks— 510(k) K232836

Substantially Equivalent

Dimar S.P.A.

FDA 510(k) clearance K232836 for Family of DIMAR DMAX NIV masks, Substantially Equivalent on 2024-08-14. Applicant: Dimar S.P.A..

Clearance details

Applicant: Dimar S.P.A.
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 2023-09-14
Decision date: 2024-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medolla, IT

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.