K-number	K180200
Device name	ESG-300, APU-300, Pressure Reducer, MAPC Probes
Applicant	Olympus Winter & Ibe GmbH
Product code	GEI
Device class	Class II
Decision date	Apr 26, 2018
Decision	Substantially Equivalent
Regulation	878.4400

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View the full FDA submission: accessdata.fda.gov

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ESG-300, APU-300, Pressure Reducer, MAPC Probes

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