K-number	K172822
Device name	Azurion series R1.2
Applicant	Philips Medical Systems Nederland B.V.
Product code	OWB
Device class	Class II
Decision date	Nov 22, 2017
Decision	Substantially Equivalent
Regulation	892.1650

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Source

View the full FDA submission: accessdata.fda.gov

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Azurion series R1.2

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