NEVONI CLASSIC, MODEL 6600-PO— 510(k) K082878

Substantially Equivalent

Nsr Comercio E Representacoes Ltda

FDA 510(k) clearance K082878 for NEVONI CLASSIC, MODEL 6600-PO, Substantially Equivalent on 2008-12-30. Applicant: Nsr Comercio E Representacoes Ltda.

Clearance details

Applicant: Nsr Comercio E Representacoes Ltda
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2008-09-29
Decision date: 2008-12-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Foxboro, 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.