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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 K171406
Device Name Optum TeleHealth Application
Applicant
United Health Group Inc.
1100 King Street, Buliding 6, Suite 300
rye brook,  NY  10573
Applicant Contact donald j. matthews
Correspondent
United Health Group Inc.
1100 King Street, Buliding 6, Suite 300
rye brook,  NY  10573
Correspondent Contact donald j. matthews
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
DQA   DXN  
Date Received05/12/2017
Decision Date 08/18/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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