Name: Predicase
Price: 199 USD

K-number	K111096
Device name	VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY
Applicant	Vasomedical, Inc.
Product code	DSH
Device class	Class II
Decision date	Jun 24, 2011
Decision	Substantially Equivalent
Regulation	870.2800

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Source

View the full FDA submission: accessdata.fda.gov

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VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY

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