PRESSON ELECTRODE— 510(k) K121347

Clearance details

Applicant

Rhythmlink International, LLC

Product code

Code GXZ

Device class

Class 2

Regulation

21 CFR 882.1350

Advisory panel

Neurology

Date received

2012-05-01

Decision date

2012-07-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Columbia, SC, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121347.