Name: Predicase
Price: 199 USD

K-number	K252160
Device name	Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
Applicant	Persyst Development, LLC
Product code	OMB
Device class	Class II
Decision date	Oct 31, 2025
Decision	Substantially Equivalent
Regulation	882.1400

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))

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