CUTANEOUS ELECTRODE— 510(k) K052188

Substantially Equivalent

Rhythmlink International, LLC

FDA 510(k) clearance K052188 for CUTANEOUS ELECTRODE, Substantially Equivalent on 2005-08-23. Applicant: Rhythmlink International, LLC. Device class: 2.

Clearance details

Applicant
Rhythmlink International, LLC
Product code
Code GXY
Device class
Class 2
Regulation
21 CFR 882.1320
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Columbia, SC, US
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