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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 K203088
Device Name Infinity Acute Care System (IACS) Monitoring System
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 Deborah Herrington
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BSZ   BTL   BZQ   CBK   CBQ  
CBR   CBS   CCK   CCL   DPS   DQA  
DQE   DRT   DSA   DSB   DSF   DSI  
DSK   DXN   FLL   FLS   IPF   KOI  
MLD   MSX   NHO   NHP   NHQ   OLT  
OLW   OMC   ORT  
Date Received10/13/2020
Decision Date 02/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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