NICOLET PIONEER TC8080— 510(k) K020754

Substantially Equivalent

Nicolet Biomedical

FDA 510(k) clearance K020754 for NICOLET PIONEER TC8080, Substantially Equivalent on 2003-04-21. Applicant: Nicolet Biomedical.

Clearance details

Applicant: Nicolet Biomedical
Product code: Code IYN
Advisory panel: Radiology
Date received: 2002-03-07
Decision date: 2003-04-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Stoughton, WI, US

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Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

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.