K-number	K233800
Device name	Vertos mild Device Kit (MDK-0002)
Applicant	Vertos Medical, Inc.
Product code	HRX
Device class	Class II
Decision date	May 6, 2024
Decision	Substantially Equivalent
Regulation	888.1100

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Source

View the full FDA submission: accessdata.fda.gov

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Vertos mild Device Kit (MDK-0002)

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