X4 SYSTEM— 510(k) K130013

Substantially Equivalent

Advanced Brain Monitoring, Inc.

FDA 510(k) clearance K130013 for X4 SYSTEM, Substantially Equivalent on 2013-01-31. Applicant: Advanced Brain Monitoring, Inc..

Clearance details

Applicant: Advanced Brain Monitoring, Inc.
Product code: Code OMC
Advisory panel: Neurology
Date received: 2013-01-02
Decision date: 2013-01-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Dousman, WI, US

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