K-number	K182847
Device name	Hudson RCI Voldyne Volumetric Exerciser
Applicant	Teleflexmedical, Inc.
Product code	BWF
Device class	Class II
Decision date	Jul 1, 2019
Decision	Substantially Equivalent
Regulation	868.5690

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Source

View the full FDA submission: accessdata.fda.gov

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Hudson RCI Voldyne Volumetric Exerciser

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