Guardian Needle Electrode— 510(k) K200984

Substantially Equivalent

Rhythmlink International, LLC

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

Clearance details

Applicant
Rhythmlink International, LLC
Product code
Code GXZ
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Columbia, SC, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.