K-number	K220533
Device name	Endoscopy Oxygen Mask
Applicant	Engineered Medical Systems, Inc.
Product code	CCK
Device class	Class II
Decision date	Nov 16, 2022
Decision	Substantially Equivalent
Regulation	868.1400

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Source

View the full FDA submission: accessdata.fda.gov

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Endoscopy Oxygen Mask

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