K-number	K163378
Device name	Monarch Airway Clearance System
Applicant	Hill-Rom Services Pte, Ltd.
Product code	BYI
Device class	Class II
Decision date	Mar 17, 2017
Decision	Substantially Equivalent
Regulation	868.5665

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View the full FDA submission: accessdata.fda.gov

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Monarch Airway Clearance System

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