Name: Predicase
Price: 199 USD

K-number	K042642
Device name	AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR)
Applicant	Ge Medical Systems Information Technologies
Product code	MHX
Device class	Class II
Decision date	Nov 3, 2004
Decision	Substantially Equivalent
Regulation	870.1025

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Source

View the full FDA submission: accessdata.fda.gov

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AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR)

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