LUNA— 510(k) K982351

Name: FDA 510(k) clearance K982351
Creator: U.S. Food and Drug Administration
Published: 1998-07-29

Substantially Equivalent

Stellate Systems

FDA 510(k) clearance K982351 for LUNA, Substantially Equivalent on 1998-07-29. Applicant: Stellate Systems. Device class: 2.

Clearance details

Applicant: Stellate Systems
Product code: Code OLT
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1998-07-06
Decision date: 1998-07-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Canada, H32 2n2, CA

Download summary PDF View on FDA.gov ↗

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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.