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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 Drive, Suite A
Charlottesville,  VA  22901
Applicant Contact Jeff Pompeo
Correspondent
Caretaker Medical, LLC
3042 Berkmar Drive, 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
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