PressOn Electrode Headset— 510(k) K190801

Name: FDA 510(k) clearance K190801
Creator: U.S. Food and Drug Administration
Published: 2019-07-10

Substantially Equivalent

Rhythmlink International, LLC

FDA 510(k) clearance K190801 for PressOn Electrode Headset, Substantially Equivalent on 2019-07-10. 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: 2019-03-29
Decision date: 2019-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, SC, US

Download summary PDF View on FDA.gov ↗

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