K-number	K172154
Device name	Isolette 8000 plus
Applicant	Draeger Medical Sytems, Inc.
Product code	FMZ
Device class	Class II
Decision date	Apr 19, 2018
Decision	Substantially Equivalent
Regulation	880.5400

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Source

View the full FDA submission: accessdata.fda.gov

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Isolette 8000 plus

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