Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))— 510(k) K252160

Name: FDA 510(k) clearance K252160
Creator: U.S. Food and Drug Administration
Published: 2025-10-31

Substantially Equivalent

Persyst Development, LLC

FDA 510(k) clearance K252160 for Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)), Substantially Equivalent on 2025-10-31. Applicant: Persyst Development, LLC. Device class: 2.

Clearance details

Applicant: Persyst Development, LLC
Product code: Code OMB
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2025-07-10
Decision date: 2025-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solana Beach, CA, US

Download summary PDF View on FDA.gov ↗

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