Name: Predicase
Price: 199 USD

K-number	K052795
Device name	PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30
Applicant	Philips Medizin Systeme Boeblingen GmbH
Product code	HGM
Device class	Class II
Decision date	Dec 30, 2005
Decision	Substantially Equivalent
Regulation	884.2740

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Source

View the full FDA submission: accessdata.fda.gov

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PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30

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