Name: Predicase
Price: 199 USD

K-number	K173028
Device name	BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software
Applicant	Healthstats International Pte. , Ltd.
Product code	DXN
Device class	Class II
Decision date	Jun 21, 2018
Decision	Substantially Equivalent
Regulation	870.1130

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software

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