K-number	K190801
Device name	PressOn Electrode Headset
Applicant	Rhythmlink International, LLC
Product code	GXZ
Device class	Class II
Decision date	Jul 10, 2019
Decision	Substantially Equivalent
Regulation	882.1350

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Source

View the full FDA submission: accessdata.fda.gov

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PressOn Electrode Headset

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