K-number	K193028
Device name	MEDRAD Mark 7 Arterion Injection System
Applicant	Bayer Medical Care, Inc.
Product code	DXT
Device class	Class II
Decision date	Dec 5, 2019
Decision	Substantially Equivalent
Regulation	870.1650

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View the full FDA submission: accessdata.fda.gov

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MEDRAD Mark 7 Arterion Injection System

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