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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 K170973
Device Name VitalWatch Software User Interface
Applicant
VitalConnect, Inc.
224 Airport Parkway, Suite 300
san jose,  CA  95110
Applicant Contact kevin potgieter
Correspondent
VitalConnect, Inc.
224 Airport Parkway, Suite 300
san jose,  CA  95110
Correspondent Contact kevin potgieter
Regulation Number870.2910
Classification Product Code
DRG  
Date Received04/03/2017
Decision Date 06/02/2017
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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