K-number	K100797
Device name	FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS
Applicant	Edan Instruments, Inc.
Product code	HGM
Device class	Class II
Decision date	Nov 10, 2010
Decision	Substantially Equivalent
Regulation	884.2740

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View the full FDA submission: accessdata.fda.gov

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FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS

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