IdentEvent— 510(k) K150688

Substantially Equivalent

Optima Neuroscience, Inc.

FDA 510(k) clearance K150688 for IdentEvent, Substantially Equivalent on 2015-11-05. Applicant: Optima Neuroscience, Inc.. Device class: 2.

Clearance details

Applicant: Optima Neuroscience, Inc.
Product code: Code OMB
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2015-03-17
Decision date: 2015-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alachua, FL, US

Download summary PDF View on FDA.gov ↗

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