Name: Predicase
Price: 199 USD

K-number	K231984
Device name	Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)
Applicant	Shenzhen Hingmed Medical Instrument Co., Ltd.
Product code	DXN
Device class	Class II
Decision date	Mar 26, 2024
Decision	Substantially Equivalent
Regulation	870.1130

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Source

View the full FDA submission: accessdata.fda.gov

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Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)

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