K012466

Substantially Equivalent

BIS/EEG MODULE

Applicant: General Electric Medical Systems Information Techn
Product code: OLW
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 ↗

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