ECLIPSE VERSION 3.0— 510(k) K955577

Substantially Equivalent

Stellate Systems

FDA 510(k) clearance K955577 for ECLIPSE VERSION 3.0, Substantially Equivalent on 1996-09-20. Applicant: Stellate Systems.

Clearance details

Applicant: Stellate Systems
Product code: Code OLT
Advisory panel: Neurology
Date received: 1995-11-08
Decision date: 1996-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada, H32 2n2, CA

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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.