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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, positive pressure breathing, intermittent
510(k) Number K192143
Device Name Maximus System
Applicant
Hill-Rom Services Pte Ltd
1 Yishun Ave 7
Singapore,  SG
Applicant Contact Alvin Tan
Correspondent
Hill-Rom Services Pte Ltd
1 Yishun Ave 7
Singapore,  SG
Correspondent Contact Paul Dryden
Regulation Number868.5905
Classification Product Code
NHJ  
Date Received08/08/2019
Decision Date 02/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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