K-number	K193268
Device name	APrioCore Plus
Applicant	Apriomed AB
Product code	KNW
Device class	Class II
Decision date	Feb 27, 2020
Decision	Substantially Equivalent
Regulation	876.1075

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Source

View the full FDA submission: accessdata.fda.gov

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APrioCore Plus

Everything you need for a 510(k) submission. Nothing you don't.