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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K203579
Device Name Infinity Gateway Suite
Applicant
Draeger Medical Systems, Inc.
6 Tech Dr.
Andover,  MA  01810
Applicant Contact Eileen M Boyle
Correspondent
Draeger Medical Systems, Inc.
6 Tech Dr.
Andover,  MA  01810
Correspondent Contact Eileen M Boyle
Regulation Number870.2300
Classification Product Code
MSX  
Date Received12/07/2020
Decision Date 06/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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