K-number	K232788
Device name	INSPIRA ART100
Applicant	Inspira Technologies Oxy B.H.N. , Ltd.
Product code	DWA
Device class	Class II
Decision date	May 24, 2024
Decision	Substantially Equivalent
Regulation	870.4380

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Source

View the full FDA submission: accessdata.fda.gov

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INSPIRA ART100

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