PressOn Electrode Headset— 510(k) K190801

Substantially Equivalent

Rhythmlink International, LLC

FDA 510(k) clearance K190801 for PressOn Electrode Headset, Substantially Equivalent on 2019-07-10. 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
Traditional
Location
Columbia, SC, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.