BIS/EEG MODULE— 510(k) K012466

Name: FDA 510(k) clearance K012466
Creator: U.S. Food and Drug Administration
Published: 2001-10-01

Substantially Equivalent

General Electric Medical Systems Information Techn

FDA 510(k) clearance K012466 for BIS/EEG MODULE, Substantially Equivalent on 2001-10-01. Applicant: General Electric Medical Systems Information Techn. Device class: 2.

Clearance details

Applicant: General Electric Medical Systems Information Techn
Product code: Product code OLW
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2001-08-01
Decision date: 2001-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

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