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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 K230996
Device Name Pursuant Health Kiosk (G1.D5)
Applicant
Pursuant Health
11350 Old Roswell Rd.
Suite 900
Alpharetta,  GA  30009
Applicant Contact Leslie Sommers
Correspondent
Regsolutions, LLC
174 Watercolor Way
Suite 103-403
Santa Rosa Beach,  FL  32459
Correspondent Contact Penny Northcutt
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Code
QZP  
Date Received04/07/2023
Decision Date 01/04/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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