MR CONDITIONAL PRESSON ELECTRODE— 510(k) K130220

Clearance details

Applicant

Rhythmlink International, LLC

Product code

Code GXZ

Device class

Class 2

Regulation

21 CFR 882.1350

Advisory panel

Neurology

Date received

2013-01-29

Decision date

2013-07-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Columbia, SC, US

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