Name: Predicase
Price: 199 USD

K-number	K241007
Device name	Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)
Applicant	Shenzhen Urion Technology Co., Ltd.
Product code	DXN
Device class	Class II
Decision date	Oct 24, 2024
Decision	Substantially Equivalent
Regulation	870.1130

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Source

View the full FDA submission: accessdata.fda.gov

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Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)

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