K-number	K092890
Device name	ASTHMA MONITOR AM3
Applicant	Carefusion Germany 234 GmbH
Product code	BZG
Device class	Class II
Decision date	Jan 13, 2010
Decision	Substantially Equivalent
Regulation	868.1840

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View the full FDA submission: accessdata.fda.gov

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ASTHMA MONITOR AM3

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