K-number	K221058
Device name	LungTrainer (MD2 & MD3)
Applicant	Lung Trainers, LLC
Product code	BWF
Device class	Class II
Decision date	Jul 5, 2023
Decision	Substantially Equivalent
Regulation	868.5690

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Source

View the full FDA submission: accessdata.fda.gov

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LungTrainer (MD2 & MD3)

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