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.. Device class: 2.

Clearance details

Applicant
Cane S.R.L.
Product code
Code FRN
Device class
Class 2
Regulation
21 CFR 880.5725
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Rivoli-Cascine Vica (Torino), IT
Download summary PDFView on FDA.gov ↗

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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, through . 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.