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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Percussor, Powered-Electric
510(k) Number K173603
Device Name Monarch Airway Clearance System
Applicant
Hill-Rom Holdings, Inc.
1 Yishun Ave. 7
Singapore,  SG
Applicant Contact Joseph Braido
Correspondent
Hill-Rom Holdings, Inc.
1 Yishun Ave. 7
Singapore,  SG
Correspondent Contact Paul Dryden
Regulation Number868.5665
Classification Product Code
BYI  
Date Received11/21/2017
Decision Date 10/24/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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