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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 K201764
Device Name Infinity Acute Care System (IACS) Monitoring Solution
Applicant
Draeger Medical Systems, Inc.
6 Tech Dr.
Andover,  MA  01810
Applicant Contact Tom Hirte
Correspondent
Draeger Medical Systems, Inc.
6 Tech Dr.
Andover,  MA  01810
Correspondent Contact Tom Hirte
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 Received06/29/2020
Decision Date 12/09/2021
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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