K-number	K182181
Device name	Persyst 14 EEG Review and Analysis Software
Applicant	Persyst Development Corporation
Product code	OMB
Device class	Class II
Decision date	Nov 29, 2018
Decision	Substantially Equivalent
Regulation	882.1400

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Source

View the full FDA submission: accessdata.fda.gov

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Persyst 14 EEG Review and Analysis Software

Everything you need for a 510(k) submission. Nothing you don't.