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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K221742
Device Name CONNEQT PULSE
Applicant
Atcor Medical
# 3 Jin Ping St.,Ya An Rd., Nankai District
Sydney,  AU 2000
Applicant Contact Toni Hofhine
Correspondent
Heyer Regulatory Soilutions
125 Cherry Lane
Amherst,  MA  01002
Correspondent Contact Sheila Hemeon-Heyer
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Code
DSK  
Date Received06/15/2022
Decision Date 04/21/2023
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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