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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 K132803
Device Name MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK
Applicant
MEDAPPS INC., DBA ALERE CONNECT
8767 E. VIA DE VENTURA, STE 300
scottsdale,  AZ  85258
Applicant Contact kent dicks
Correspondent
MEDAPPS INC., DBA ALERE CONNECT
8767 E. VIA DE VENTURA, STE 300
scottsdale,  AZ  85258
Correspondent Contact kent dicks
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Code
NBW  
Date Received09/06/2013
Decision Date 12/12/2013
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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