Name: Predicase
Price: 199 USD

K-number	K033030
Device name	CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM
Applicant	Witt Biomedical Corp
Product code	MWI
Device class	Class II
Decision date	Feb 24, 2004
Decision	Substantially Equivalent
Regulation	870.2300

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Source

View the full FDA submission: accessdata.fda.gov

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CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM

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