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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K260579
Device Name Infinity® Acute Care System (IACS) – VG8.1
Applicant
Draeger Medical Systems, Inc.
6 Tech Dr.
Andover,  MA  01810
Applicant Contact Deborah Herrington
Correspondent
Draeger Medical Systems, Inc.
6 Tech Dr.
Andover,  MA  01810
Correspondent Contact Melissa Gray
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BZQ   CCK   DPS   DQA   DQE  
DRT   DSA   DSB   DSF   DSI   DSK  
DXG   DXN   FLL   MLD   MSX  
Date Received02/20/2026
Decision Date 08/20/2026
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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