K-number	K170037
Device name	Breathe Technologies Life2000 Ventilation System
Applicant	Breathe Technologies
Product code	CBK
Device class	Class II
Decision date	Aug 11, 2017
Decision	Substantially Equivalent
Regulation	868.5895

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Source

View the full FDA submission: accessdata.fda.gov

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Breathe Technologies Life2000 Ventilation System

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Breathe Technologies Life2000 Ventilation System