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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 K124000
Device Name MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM
Applicant
Medapps Inc., Dba Alere Connect
8767 E. Via De Ventura, Suite 300
Scottsdale,  AZ  85258
Applicant Contact KENT DICKS
Correspondent
Medapps Inc., Dba Alere Connect
8767 E. Via De Ventura, Suite 300
Scottsdale,  AZ  85258
Correspondent Contact KENT DICKS
Regulation Number870.2910
Classification Product Code
DRG  
Date Received12/26/2012
Decision Date 07/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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