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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 (Without Arrhythmia Detection Or Alarms)
510(k) Number K230881
Device Name Change Healthcare Cardiology Hemodynamics™
Applicant
Change Healthcare Israel , Ltd.
26 Harokmim St.
Holon,  IL 5885849
Applicant Contact Alona Golik
Correspondent
Change Healthcare Israel , Ltd.
26 Harokmim St.
Holon,  IL 5885849
Correspondent Contact Alona Golik
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Code
DQK  
Date Received03/30/2023
Decision Date 09/11/2023
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
Recalls CDRH Recalls
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