CRONO S-PID 50— 510(k) K091042

Substantially Equivalent

Cane S.R.L.

FDA 510(k) clearance K091042 for CRONO S-PID 50, Substantially Equivalent on 2009-05-12. Applicant: Cane S.R.L..

Clearance details

Applicant: Cane S.R.L.
Product code: Code FRN
Advisory panel: General Hospital
Date received: 2009-04-13
Decision date: 2009-05-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Rivoli-Cascine Vica (Torino), IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

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.