K-number	K173197
Device name	Reusable NIBP Cuff
Applicant	Orantech, Inc.
Product code	DXQ
Device class	Class II
Decision date	Aug 21, 2018
Decision	Substantially Equivalent
Regulation	870.1120

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Source

View the full FDA submission: accessdata.fda.gov

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Reusable NIBP Cuff

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