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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 K062662
Device Name TELEMEDICINE SYSTEM MODEL VMS-01
Applicant
MEDIC4ALL (ISRAEL) LTD.
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004 -1109
Applicant Contact JONATHAN S KAHAN
Correspondent
MEDIC4ALL (ISRAEL) LTD.
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004 -1109
Correspondent Contact JONATHAN S KAHAN
Regulation Number870.2910
Classification Product Code
DRG  
Date Received09/07/2006
Decision Date 11/21/2006
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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