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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 K163255
Device Name CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor
Applicant
Caretaker Medical, LLC
3042 Berkmar Dr., Suite A
Charlottesville,  VA  22901
Applicant Contact Jeff Pompeo
Correspondent
Caretaker Medical, LLC
3042 Berkmar Dr., Suite A
Charlottesville,  VA  22901
Correspondent Contact Jeff Pompeo
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Code
DRG  
Date Received11/21/2016
Decision Date 04/21/2017
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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