Name: Predicase
Price: 199 USD

K-number	K032882
Device name	RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100
Applicant	Recom Managed Systems, Inc.
Product code	MWJ
Device class	Class II
Decision date	Jan 28, 2004
Decision	Substantially Equivalent
Regulation	870.2800

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Source

View the full FDA submission: accessdata.fda.gov

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RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100

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