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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 K233834
Device Name Infinity Gateway Suite
Applicant
Draeger Medical Systems, Inc.
6 Tech Dr.
Andover,  MA  01810
Applicant Contact Chris Riel
Correspondent
Draeger Medical Systems, Inc.
6 Tech Dr.
Andover,  MA  01810
Correspondent Contact Megan Brewster
Regulation Number870.2300
Classification Product Code
MSX  
Date Received12/04/2023
Decision Date 07/12/2024
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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