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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K223049
Device Name CardioSTAT® ECG Test Solution
Applicant
Icentia, Inc.
2750 Einstein St.
Quebec,  CA G1P4R1
Applicant Contact Danièle Grondines
Correspondent
Ultra Life Science Solutions, Inc.
2811 Milton Ave. #409
Janesville,  WI  53545
Correspondent Contact Christina Henza
Regulation Number870.2800
Classification Product Code
DSH  
Subsequent Product Code
DQK  
Date Received09/29/2022
Decision Date 03/22/2023
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
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