PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE— 510(k) K132306

Name: FDA 510(k) clearance K132306
Creator: U.S. Food and Drug Administration
Published: 2013-11-21

Substantially Equivalent

Persyst Development Corp.

FDA 510(k) clearance K132306 for PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE, Substantially Equivalent on 2013-11-21. Applicant: Persyst Development Corp.. Device class: 2.

Clearance details

Applicant: Persyst Development Corp.
Product code: Code OMB
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2013-07-24
Decision date: 2013-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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