Name: Predicase
Price: 199 USD

K-number	K011310
Device name	NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-1
Applicant	Nien Made Electrnics Corp.
Product code	DXN
Device class	Class II
Decision date	Jul 20, 2001
Decision	Substantially Equivalent
Regulation	870.1130

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Source

View the full FDA submission: accessdata.fda.gov

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NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-1

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