Name: Predicase
Price: 199 USD

K-number	K222153
Device name	Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)
Applicant	Microlife Intellectual Property GmbH
Product code	DXN
Device class	Class II
Decision date	Feb 3, 2023
Decision	Substantially Equivalent
Regulation	870.1130

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Source

View the full FDA submission: accessdata.fda.gov

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Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)

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