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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 K200988
Device Name Maximus System
Applicant
Hill-Rom Services Pte, Ltd.
1 Yishun Ave. 7
Singapore,  SG 768923
Applicant Contact Alvin Tan
Correspondent
Hill-Rom Services Pte, Ltd.
1 Yishun Ave. 7
Singapore,  SG 768923
Correspondent Contact Paul Dryden
Regulation Number868.5905
Classification Product Code
NHJ  
Date Received04/15/2020
Decision Date 05/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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