Name: Predicase
Price: 199 USD

K-number	K032290
Device name	FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR
Applicant	Fukuda Denshi USA, Inc.
Product code	MHX
Device class	Class II
Decision date	Oct 10, 2003
Decision	Substantially Equivalent
Regulation	870.1025

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Source

View the full FDA submission: accessdata.fda.gov

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FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR

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