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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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