GUARDIAN, EEG BRAIN MONITORING SYSTEM— 510(k) K874733

Substantially Equivalent

Tracor Northern, Inc.

FDA 510(k) clearance K874733 for GUARDIAN, EEG BRAIN MONITORING SYSTEM, Substantially Equivalent on 1988-02-29. Applicant: Tracor Northern, Inc..

Clearance details

Applicant: Tracor Northern, Inc.
Product code: Code OLT
Advisory panel: Neurology
Date received: 1987-11-18
Decision date: 1988-02-29
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.