K-number	K150298
Device name	Entropy Module, E-ENTROPY-01
Applicant	Ge Healthcare Filand OY
Product code	OLW
Device class	Class II
Decision date	Nov 12, 2015
Decision	Substantially Equivalent
Regulation	882.1400

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View the full FDA submission: accessdata.fda.gov

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Entropy Module, E-ENTROPY-01

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