510(k) K050263— MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU

Substantially Equivalent

M.O. Com S.R.L.

Clearance details

Applicant: M.O. Com S.R.L.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 2005-02-04
Decision date: 2006-11-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Buccinasco (Mi), IT

Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

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.