Name: Predicase
Price: 199 USD

K-number	K152040
Device name	X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)
Applicant	Advanced Brain Monitoring, Inc.
Product code	OMC
Device class	Class II
Decision date	Oct 30, 2015
Decision	Substantially Equivalent
Regulation	882.1400

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Source

View the full FDA submission: accessdata.fda.gov

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X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)

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