Persyst 14 EEG Review and Analysis Software— 510(k) K182181

Name: FDA 510(k) clearance K182181
Creator: U.S. Food and Drug Administration
Published: 2018-11-29

Substantially Equivalent

Persyst Development Corporation

FDA 510(k) clearance K182181 for Persyst 14 EEG Review and Analysis Software, Substantially Equivalent on 2018-11-29. Applicant: Persyst Development Corporation. Device class: 2.

Clearance details

Applicant: Persyst Development Corporation
Product code: Code OMB
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2018-08-13
Decision date: 2018-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solana Beach, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.