VIGILANT EEG MONITOR MODEL VIGILANT 2.0— 510(k) K101386

Name: FDA 510(k) clearance K101386
Creator: U.S. Food and Drug Administration
Published: 2010-07-30

Substantially Equivalent

Infinite Biomedical Technologies, LLC

FDA 510(k) clearance K101386 for VIGILANT EEG MONITOR MODEL VIGILANT 2.0, Substantially Equivalent on 2010-07-30. Applicant: Infinite Biomedical Technologies, LLC. Device class: 2.

Clearance details

Applicant: Infinite Biomedical Technologies, LLC
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2010-05-18
Decision date: 2010-07-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

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