K-number	K203155
Device name	BreatheSuite MDI V1
Applicant	Breathesuite, Inc.
Product code	CAF
Device class	Class II
Decision date	Sep 17, 2021
Decision	Substantially Equivalent
Regulation	868.5630

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Source

View the full FDA submission: accessdata.fda.gov

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BreatheSuite MDI V1

Everything you need for a 510(k) submission. Nothing you don't.