Name: Predicase
Price: 199 USD

K-number	K221372
Device name	YUWELL Electronic Blood Pressure Monitor
Applicant	Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Product code	DXN
Device class	Class II
Decision date	Oct 17, 2022
Decision	Substantially Equivalent
Regulation	870.1130

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Source

View the full FDA submission: accessdata.fda.gov

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YUWELL Electronic Blood Pressure Monitor

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