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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
Recalls CDRH Recalls
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