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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 K120895
Device Name REMOTE PRESENCE SYSTEM
Applicant
INTOUCH HEALTH, INC.
6330 HOLLISTER AVE.
GOLETA,  CA  93117
Applicant Contact STEVE SIDWELL
Correspondent
INTOUCH HEALTH, INC.
6330 HOLLISTER AVE.
GOLETA,  CA  93117
Correspondent Contact STEVE SIDWELL
Regulation Number870.2910
Classification Product Code
DRG  
Date Received03/23/2012
Decision Date 05/24/2012
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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