Guardian Needle Electrode— 510(k) K200984

Name: FDA 510(k) clearance K200984
Creator: U.S. Food and Drug Administration
Published: 2020-05-27

Substantially Equivalent

Rhythmlink International, LLC

FDA 510(k) clearance K200984 for Guardian Needle Electrode, Substantially Equivalent on 2020-05-27. Applicant: Rhythmlink International, LLC. Device class: 2.

Clearance details

Applicant: Rhythmlink International, LLC
Product code: Code GXZ
Device class: Class 2
Regulation: 21 CFR 882.1350
Advisory panel: Neurology
Date received: 2020-04-14
Decision date: 2020-05-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Columbia, SC, 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.