BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE— 510(k) K990538

Name: FDA 510(k) clearance K990538
Creator: U.S. Food and Drug Administration
Published: 1999-05-19

Substantially Equivalent

Brainmaster

FDA 510(k) clearance K990538 for BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE, Substantially Equivalent on 1999-05-19. Applicant: Brainmaster. Device class: 2.

Clearance details

Applicant: Brainmaster
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 1999-02-19
Decision date: 1999-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.