K-number	K242591
Device name	XERO-alpha
Applicant	DRTECH Corporation
Product code	EHD
Device class	Class II
Decision date	Nov 1, 2024
Decision	Substantially Equivalent
Regulation	872.1800

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Source

View the full FDA submission: accessdata.fda.gov

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XERO-alpha

Everything you need for a 510(k) submission. Nothing you don't.