CDSA(COLOR DENSITY, SPECTRAL ARRRAY)— 510(k) K852587

Substantially Equivalent

Tracor Northern, Inc.

FDA 510(k) clearance K852587 for CDSA(COLOR DENSITY, SPECTRAL ARRRAY), Substantially Equivalent on 1985-08-16. Applicant: Tracor Northern, Inc..

Clearance details

Applicant: Tracor Northern, Inc.
Product code: Code OLT
Advisory panel: Neurology
Date received: 1985-06-18
Decision date: 1985-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middleton, WI, US

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Adverse events under product code OLT

product code OLT

Other: 1
Total: 1

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.