K-number	K183394
Device name	CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO
Applicant	GE Healthcare Finland Oy
Product code	CCK
Device class	Class II
Decision date	May 1, 2019
Decision	Substantially Equivalent
Regulation	868.1400

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View the full FDA submission: accessdata.fda.gov

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CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO

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