X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)— 510(k) K152040

Substantially Equivalent

Advanced Brain Monitoring, Inc.

FDA 510(k) clearance K152040 for X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29), Substantially Equivalent on 2015-10-30. Applicant: Advanced Brain Monitoring, Inc..

Clearance details

Applicant: Advanced Brain Monitoring, Inc.
Product code: Code OMC
Advisory panel: Neurology
Date received: 2015-07-22
Decision date: 2015-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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