PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE— 510(k) K151929

Name: FDA 510(k) clearance K151929
Creator: U.S. Food and Drug Administration
Published: 2015-08-12

Substantially Equivalent

Persyst Development Corporation

FDA 510(k) clearance K151929 for PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE, Substantially Equivalent on 2015-08-12. 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: 2015-07-14
Decision date: 2015-08-12
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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