NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM— 510(k) K013419

Substantially Equivalent

Nicolet Biomedical

FDA 510(k) clearance K013419 for NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM, Substantially Equivalent on 2001-12-20. Applicant: Nicolet Biomedical.

Clearance details

Applicant: Nicolet Biomedical
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2001-10-15
Decision date: 2001-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.