K-number	K201082
Device name	LTV2 Series Ventilators
Applicant	Vyaire Medical, Inc.
Product code	CBK
Device class	Class II
Decision date	Nov 10, 2021
Decision	Substantially Equivalent
Regulation	868.5895

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Source

View the full FDA submission: accessdata.fda.gov

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LTV2 Series Ventilators

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