AccuPoint Electrode— 510(k) K162459

Name: FDA 510(k) clearance K162459
Creator: U.S. Food and Drug Administration
Published: 2017-06-15

Substantially Equivalent

Microprobes For Life Science, Inc. Dba Neuron

FDA 510(k) clearance K162459 for AccuPoint Electrode, Substantially Equivalent on 2017-06-15. Applicant: Microprobes For Life Science, Inc. Dba Neuron. Device class: 2.

Clearance details

Applicant: Microprobes For Life Science, Inc. Dba Neuron
Product code: Code GZL
Device class: Class 2
Regulation: 21 CFR 882.1330
Advisory panel: Neurology
Date received: 2016-09-02
Decision date: 2017-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

Download summary PDF View on FDA.gov ↗

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