FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB— 510(k) K062014

Substantially Equivalent

Flaem Nuova S.P.A.

FDA 510(k) clearance K062014 for FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB, Substantially Equivalent on 2007-03-22. Applicant: Flaem Nuova S.P.A..

Clearance details

Applicant: Flaem Nuova S.P.A.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2006-07-17
Decision date: 2007-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Reading, MA, US

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Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.