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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 K213699
Device Name CareTaker Monitor App
Applicant
Caretaker Medical, LLC
941 Glenwood Station Ln., Suite 301
Charlottesville,  VA  22901
Applicant Contact Jeff Pompeo
Correspondent
Caretaker Medical, LLC
941 Glenwood Station Ln., Suite 301
Charlottesville,  VA  22901
Correspondent Contact Jeff Pompeo
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Code
DRG  
Date Received11/23/2021
Decision Date 03/30/2022
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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