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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor, physiological, patient(with arrhythmia detection or alarms)
510(k) Number K151027
Device Name zensor system
Applicant
INTELESENS LIMITED
17 HERON ROAD
belfast,  GB bt3 9le
Applicant Contact patricia pepper
Correspondent
PROMEDIC, INC.
24301 WOODSAGE DRIVE
bonita springs,  FL  34134 -2958
Correspondent Contact paul dryden
Regulation Number870.1025
Classification Product Code
MHX  
Date Received04/17/2015
Decision Date 10/02/2015
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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