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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 K163378
Device Name Monarch Airway Clearance System
Applicant
Hill-Rom Services Pte, Ltd.
1 Yishun Ave. 7
Singapore,  SG
Applicant Contact Huifang Zhu
Correspondent
Hill-Rom Services Pte, Ltd.
1 Yishun Ave. 7
Singapore,  SG
Correspondent Contact Paul Dryden
Regulation Number868.5665
Classification Product Code
BYI  
Date Received12/01/2016
Decision Date 03/17/2017
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
Recalls CDRH Recalls
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