BRAINTRACE— 510(k) K940811

Name: FDA 510(k) clearance K940811
Creator: U.S. Food and Drug Administration
Published: 1995-05-02

Substantially Equivalent

Brainstorms Monitoring Corp.

FDA 510(k) clearance K940811 for BRAINTRACE, Substantially Equivalent on 1995-05-02. Applicant: Brainstorms Monitoring Corp.. Device class: 2.

Clearance details

Applicant: Brainstorms Monitoring Corp.
Product code: Code OLT
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1994-02-22
Decision date: 1995-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thousand Oaks, CA, US

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.