K-number	K150901
Device name	Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express
Applicant	Edan Instruments, Inc.
Product code	HGM
Device class	Class II
Decision date	Jul 1, 2015
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, models F6, F6 Express, F9, F9 Express

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