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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K181196
Device Name Caretaker Remote Display App and Caretaker Software Library
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 Number870.2910
Classification Product Code
DRG  
Date Received05/07/2018
Decision Date 10/03/2018
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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